Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

NCT00042289 | Completed Results

• 3 other identifiers: P1026s10040IMPAACT P1026s
• Study Type: observational
• Target: 1,578
• Locations: 8 countries
• Sites: 62

Brief Summary

IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

Conditions

HIV Infections

Keywords

Pregnancy; Pharmacokinetics; Treatment Experienced

Outcome Measures

Primary Outcomes (19)

• PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

  Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

• PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

  Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

• PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

  Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

  Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

• PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

• PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

• PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

• PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

• PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

• PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

• PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

• PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

• PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

• PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

• PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

• Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

• Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V. The reporting groups for this outcome reflect the drug being analyzed and are therefore not mutually exclusive. No results are available for LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug arm due to extremely low enrollment.

  Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

• Plasma Concentration for Contraceptives

  Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs.

  Measured at 6-7 weeks after contraceptive initiation postpartum

• Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

  Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

• Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

  Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule.

  Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

Secondary Outcomes (4)

• PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

  Measured at time of delivery with single cord blood and single maternal plasma sample.

• PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs

  Measured at time of delivery with single cord blood and single maternal plasma sample.

• Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs

  Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

• Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

  Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Other Outcomes (20)

• ARV Concentrations in Plasma

  Measured at intensive PK visit

• ARV Concentrations in Vaginal Secretions

  Measured at intensive PK visit

• Drug Parameter: Half-life (t1/2)

  Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.

Study Arms (49)

DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) 600/100 mg twice daily (b.i.d.) or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

Drug: darunavir/ritonavir dosage #1; Drug: darunavir/ritonavir dosage #2; Drug: darunavir/ritonavir dosage #3

DTG 50mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg once a day (q.d.).

Drug: dolutegravir

TAF 25mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.

Drug: tenofovir alafenamide fumarate (TAF)

TAF 10mg q.d. w/COBI

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI).

Drug: TAF w/cobicistat

TAF 25mg q.d. w/COBI or RTV boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting.

Drug: TAF w/cobicistat or ritonavir

EVG/COBI 150/150mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d

Drug: elvitegravir/cobicistat

DRV/COBI 800/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.

Drug: darunavir/cobicistat

ATV/COBI 300/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.

Drug: atazanavir/cobicistat

EFV 600 mg q.d. (outside THA)

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only)

Drug: efavirenz

EFV 600mg q.d. and at least one 1st line TB drug

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: * rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. * isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

Drug: efavirenz; Drug: rifampicin; Drug: ethambutol; Drug: isoniazid; Drug: pyrazinamide

LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: * rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. * isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

Drug: lopinavir/ritonavir dosage #1; Drug: rifampicin; Drug: ethambutol; Drug: isoniazid; Drug: pyrazinamide

No ARVs and at least two 1st line TB drugs

HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: * rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. * isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

Drug: rifampicin; Drug: ethambutol; Drug: isoniazid; Drug: pyrazinamide

At least two 2nd line TB drugs w/ or w/out ARVs

HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: * kanamycin * amikacin * capreomycin Fluoroquinolones: * moxifloxacin * levofloxacin * ofloxacin Oral bacteriostatic second-line agents: * ethionamide/prothionamide * terizidone/cycloserine * para-aminosalicylic acid (PAS) Other agents: * high dose INH * bedaquiline * clofazamine * delamanid * linezolid * pretomanid

Drug: kanamycin; Drug: amikacin; Drug: capreomycin; Drug: moxifloxacin; Drug: levoflaxacin; Drug: ofloxacin; Drug: ethionamide/prothionamide; Drug: terizidone/cycloserine; Drug: para-aminosalicylic acid (PAS); Drug: high dose INH; Drug: bedaquiline; Drug: clofazamine; Drug: delamanid; Drug: linezolid; Drug: pretomanid

DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

Drug: atazanavir/cobicistat; Drug: darunavir/cobicistat; Drug: ethinyl estradiol

DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting etonogestrel (ENG) implant

Drug: atazanavir/cobicistat; Drug: darunavir/cobicistat; Drug: etonogestrel implant

EFV 600mg q.d. with 30-35ug EE

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz (EFV) 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)

Drug: efavirenz; Drug: ethinyl estradiol

ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)

Drug: atazanavir/ritonavir/tenofovir dosage #1; Drug: ethinyl estradiol

NVP 200mg b.i.d

HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine (NVP) 200 mg twice a day

Drug: nevirapine

APV 1200mg b.i.d

HIV-infected pregnant women ≥ 26 weeks gestation who received amprenavir (APV) 1200mg twice a day

Drug: amprenavir

ABC 300mg b.i.d

HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir (ABC) 300mg twice a day

Drug: abacavir

LPV/RTV Arm 1: 400/100mg b.i.d

HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 400/100mg twice a day

Drug: lopinavir/ritonavir dosage #2

IDV/RTV Arm 1: 800/100mg b.i.d

HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir (IDV/RTV) 800/100 mg twice a day

Drug: indinavir/ritonavir dosage #1

FPV/RTV 700/100mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day

Drug: fosamprenavir/ritonavir

LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra (LPV/RTV) 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available

Drug: lopinavir/ritonavir dosage #2; Drug: lopinavir/ritonavir dosage #3

ATV/RTV Arm 1: 300/100mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day

Drug: atazanavir/ritonavir dosage #1

DDI 400mg or 250mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) (DDI) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg

Drug: didanosine delayed release (Videx® EC)

FTC 200mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine (FTC) 200 mg once a day

Drug: emtricitabine

TFV 300mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day

Drug: tenofovir

TFV/ATV/RTV Arm 1: 300/300/100mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day

Drug: atazanavir/ritonavir/tenofovir dosage #1

NFV Arm 1: 1250mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) \[625 mg tablets\] 1250 mg twice a day

Drug: nelfinavir dosage #1

EFV 600mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day

Drug: efavirenz

TPV/RTV 500/200mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day

Drug: tipranavir/ritonavir

LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg \[2 tablets\] twice a day until 30 weeks gestation, then 600/150 mg \[3 tablets\] twice a day until postpartum hospital discharge; and 400/100 mg \[2 tablets\] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn

Drug: lopinavir/ritonavir dosage #2; Drug: lopinavir/ritonavir dosage #4

RAL 400mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day

Drug: raltegravir

ETR 200mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day

Drug: etravirine

MVC 150 or 300mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day

Drug: maraviroc

DRV/RTV 800/100mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day

Drug: darunavir/ritonavir dosage #4

DRV/RTV 600/100mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day

Drug: darunavir/ritonavir dosage #1

ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

Drug: atazanavir/ritonavir dosage #1; Drug: atazanavir/ritonavir dosage #2

TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

Drug: atazanavir/ritonavir/tenofovir dosage #1; Drug: tenofovir/atazanavir/ritonavir dosage #2

NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) \[625 mg tablets\] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

Drug: nelfinavir dosage #1; Drug: nelfinavir dosage #2

IDV/RTV Arm 2: 400/100mg q.d. (only THA)

HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand

Drug: indinavir/ritonavir dosage #2

LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV, Alluvia tablets) 400/100 mg \[2 tablets\] twice day until 30 weeks gestation; then 600/150 mg \[3 tablets\] twice a day until postpartum hospital discharge; then 400/100 mg \[2 tablets\] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda

Drug: lopinavir/ritonavir dosage #2; Drug: lopinavir/ritonavir dosage #4

RPV 25mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.)

Drug: rilpivirine

NVP 200mg b.i.d. and RIF and at least one 1st line TB drug

HIV-infected pregnant women \> 20 weeks gestation who received nevirapine (NVP) 200 mg b.i.d AND rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. and at least one of the following drugs at study entry: * ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. * isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. * pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

Drug: ethambutol; Drug: isoniazid; Drug: pyrazinamide; Drug: nevirapine

ATV/RTV/TFV 300/100/300mg q.d. with ENG

HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant

Drug: atazanavir/ritonavir/tenofovir dosage #1; Drug: etonogestrel implant

LPV/RTV 400/100 b.i.d. with 30-35ug EE

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)

Drug: ethinyl estradiol; Drug: lopinavir/ritonavir dosage #2

LPV/RTV 400/100 b.i.d. with ENG

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant

Drug: etonogestrel implant; Drug: lopinavir/ritonavir dosage #2

EFV 600mg q.d. with ENG

HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant

Drug: efavirenz; Drug: etonogestrel implant

Interventions

atazanavir/cobicistat DRUG

atazanavir/cobicistat 300/150 mg q.d.

ATV/COBI 300/150 mg q.d.; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG

darunavir/ritonavir dosage #1 DRUG

darunavir/ritonavir twice daily 600/100 mg b.i.d.

DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.; DRV/RTV 600/100mg b.i.d.

darunavir/ritonavir dosage #2 DRUG

darunavir/ritonavir twice daily 800/100 mg b.i.d.

DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.

darunavir/ritonavir dosage #3 DRUG

darunavir/ritonavir twice daily 900/100 mg b.i.d.

DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.

elvitegravir/cobicistat DRUG

elvitegravir/cobicistat 150/150 mg q.d.

EVG/COBI 150/150mg q.d.

dolutegravir DRUG

dolutegravir 50 mg q.d.

DTG 50mg q.d.

tenofovir alafenamide fumarate (TAF) DRUG

TAF 25 mg q.d. without cobicistat or ritonavir boosting

TAF 25mg q.d.

TAF w/cobicistat DRUG

TAF 10 mg q.d. with cobicistat

TAF 10mg q.d. w/COBI

TAF w/cobicistat or ritonavir DRUG

TAF 25 mg q.d. with cobicistat or ritonavir boosting

TAF 25mg q.d. w/COBI or RTV boosting

efavirenz DRUG

efavirenz 600 mg q.d.

EFV 600 mg q.d. (outside THA); EFV 600mg q.d.; EFV 600mg q.d. and at least one 1st line TB drug; EFV 600mg q.d. with 30-35ug EE; EFV 600mg q.d. with ENG

darunavir/cobicistat DRUG

darunavir/cobicistat 800/150 mg q.d.

DRV/COBI 800/150 mg q.d.; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG

lopinavir/ritonavir dosage #1 DRUG

lopinavir/ritonavir 800/200mg b.i.d.

LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug

atazanavir/ritonavir/tenofovir dosage #1 DRUG

atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE; ATV/RTV/TFV 300/100/300mg q.d. with ENG; TFV/ATV/RTV Arm 1: 300/300/100mg q.d.; TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.

rifampicin DRUG

rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

EFV 600mg q.d. and at least one 1st line TB drug; LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug; No ARVs and at least two 1st line TB drugs

ethambutol DRUG

ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

EFV 600mg q.d. and at least one 1st line TB drug; LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug; NVP 200mg b.i.d. and RIF and at least one 1st line TB drug; No ARVs and at least two 1st line TB drugs

isoniazid DRUG

isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

EFV 600mg q.d. and at least one 1st line TB drug; LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug; NVP 200mg b.i.d. and RIF and at least one 1st line TB drug; No ARVs and at least two 1st line TB drugs

pyrazinamide DRUG

pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

EFV 600mg q.d. and at least one 1st line TB drug; LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug; NVP 200mg b.i.d. and RIF and at least one 1st line TB drug; No ARVs and at least two 1st line TB drugs

kanamycin DRUG

kanamycin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

amikacin DRUG

amikacin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

capreomycin DRUG

capreomycin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

moxifloxacin DRUG

moxifloxacin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

levoflaxacin DRUG

levofloxacin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

ofloxacin DRUG

ofloxacin (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

ethionamide/prothionamide DRUG

ethionamide/prothionamide (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

terizidone/cycloserine DRUG

terizidone/cycloserine (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

para-aminosalicylic acid (PAS) DRUG

para-aminosalicylic acid (PAS) (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

high dose INH DRUG

high dose INH (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

bedaquiline DRUG

bedaquiline (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

clofazamine DRUG

clofazamine (2nd TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

delamanid DRUG

delamanid (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

linezolid DRUG

linezolid (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

pretomanid DRUG

pretomanid (2nd line TB drug)

At least two 2nd line TB drugs w/ or w/out ARVs

ethinyl estradiol DRUG

oral contraceptives formulated with 30-35 μg ethinyl estradiol

ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE; EFV 600mg q.d. with 30-35ug EE; LPV/RTV 400/100 b.i.d. with 30-35ug EE

etonogestrel implant DRUG

etonogestrel implant contraceptive

ATV/RTV/TFV 300/100/300mg q.d. with ENG; DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG; EFV 600mg q.d. with ENG; LPV/RTV 400/100 b.i.d. with ENG

nevirapine DRUG

nevirapine 200 mg twice a day

NVP 200mg b.i.d; NVP 200mg b.i.d. and RIF and at least one 1st line TB drug

amprenavir DRUG

amprenavir 1200mg twice a day

APV 1200mg b.i.d

abacavir DRUG

abacavir 300mg twice a day

ABC 300mg b.i.d

lopinavir/ritonavir dosage #2 DRUG

lopinavir/ritonavir (Kaletra) 400/100mg twice a day

LPV/RTV 400/100 b.i.d. with 30-35ug EE; LPV/RTV 400/100 b.i.d. with ENG; LPV/RTV Arm 1: 400/100mg b.i.d; LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.; LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.; LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)

indinavir/ritonavir dosage #1 DRUG

indinavir/ritonavir 800/100mg twice a day

IDV/RTV Arm 1: 800/100mg b.i.d

fosamprenavir/ritonavir DRUG

fosamprenavir/ritonavir 700/100 mg twice a day

FPV/RTV 700/100mg b.i.d.

lopinavir/ritonavir dosage #3 DRUG

lopinavir/ritonavir (Kaletra) 533/133 mg twice a day

LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.

atazanavir/ritonavir dosage #1 DRUG

atazanavir/ritonavir 300/100 mg once a day

ATV/RTV Arm 1: 300/100mg q.d.; ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d.

didanosine delayed release (Videx® EC) DRUG

didanosine delayed release (Videx® EC) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg

DDI 400mg or 250mg q.d.

emtricitabine DRUG

emtricitabine 200 mg once a day

FTC 200mg q.d.

tenofovir DRUG

tenofovir 300 mg once a day

TFV 300mg q.d.

nelfinavir dosage #1 DRUG

nelfinavir \[625 mg tablets\] 1250 mg twice a day

NFV Arm 1: 1250mg b.i.d.; NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d.

tipranavir/ritonavir DRUG

tipranavir/ritonavir 500/200 mg twice a day

TPV/RTV 500/200mg b.i.d.

lopinavir/ritonavir dosage #4 DRUG

lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day

LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.; LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)

raltegravir DRUG

raltegravir 400 mg twice a day

RAL 400mg b.i.d.

etravirine DRUG

etravirine 200 mg twice a day

ETR 200mg b.i.d.

maraviroc DRUG

maraviroc 150 mg or 300 mg twice a day

MVC 150 or 300mg b.i.d.

atazanavir/ritonavir dosage #2 DRUG

atazanavir/ritonavir 400/100mg once a day

ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d.

tenofovir/atazanavir/ritonavir dosage #2 DRUG

tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.

nelfinavir dosage #2 DRUG

nelfinavir \[625 mg tablets\] 1875 mg twice a day

NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d.

indinavir/ritonavir dosage #2 DRUG

indinavir/ritonavir 400/100 mg twice a day

IDV/RTV Arm 2: 400/100mg q.d. (only THA)

rilpivirine DRUG

rilpivirine (25 mg q.d.)

RPV 25mg q.d.

darunavir/ritonavir dosage #4 DRUG

darunavir/ritonavir once daily 800/100 mg q.d.

DRV/RTV 800/100mg q.d.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women from IMPAACT US and non-US sites receiving the medicines specified in the protocol as part of clinical care and infants born to those women enrolled during pregnancy.

You may qualify if:

• Participant must belong to one of the following 5 groups:
• HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol
• HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry
• HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry
• HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry
• HIV-infected women 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol
• The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling
• If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation
• HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final PK sampling is completed
• For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.
• HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available.
• Participants enrolling in the 3rd trimester must enroll by 37 6/7 weeks gestation
• Participant can provide legal informed consent per local regulations
• If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment

You may not qualify if:

• Women on medicines known to interfere with absorption, metabolism, or clearance of the drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions
• If pregnant, carrying multiple fetuses
• Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study
• Infant Enrollment Criteria:
• \- All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment.
• Infant Requirements for Washout Pharmacokinetic Sampling:
• Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs)
• Birth weight greater than 1000 grams
• Is NOT receiving disallowed medications described in Section 7 of the protocol
• Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator
• Born after singleton delivery (not after multiple birth)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (62)

UAB Pediatric Infectious Diseases CRS

Birmingham, Alabama, 35233, United States

Location

University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program

La Jolla, California, 92093-0672, United States

Location

Miller Children's Hosp. Long Beach CA NICHD CRS

Long Beach, California, 90806, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90089, United States

Location

David Geffen School of Medicine at UCLA NICHD CRS

Los Angeles, California, 90095-1752, United States

Location

Univ. of California San Francisco NICHD CRS

San Francisco, California, 94143, United States

Location

Harbor UCLA Medical Ctr. NICHD CRS

Torrance, California, 90502, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 80045, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06510, United States

Location

Washington Hosp. Ctr. NICHD CRS

Washington D.C., District of Columbia, 20010, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Pediatric Perinatal HIV Clinical Trials Unit CRS

Miami, Florida, 33136, United States

Location

USF - Tampa NICHD CRS

Tampa, Florida, 33606, United States

Location

Emory University School of Medicine NICHD CRS

Atlanta, Georgia, 30322, United States

Location

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Augusta, Georgia, 30912, United States

Location

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

Chicago, Illinois, 60608, United States

Location

Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois, 60612, United States

Location

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

Chicago, Illinois, 60612, United States

Location

Lurie Children's Hospital of Chicago (LCH) CRS

Chicago, Illinois, 60614-3393, United States

Location

Tulane Univ. New Orleans NICHD CRS

New Orleans, Louisiana, 70112, United States

Location

Univ. of Maryland Baltimore NICHD CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Univ. Baltimore NICHD CRS

Baltimore, Maryland, 21287, United States

Location

Children's Hosp. of Boston NICHD CRS

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center Ped. HIV Program NICHD CRS

Boston, Massachusetts, 02118, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01605, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Rutgers - New Jersey Medical School CRS

Newark, New Jersey, 07103, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Metropolitan Hosp. NICHD CRS

New York, New York, 10029, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794, United States

Location

Bronx-Lebanon Hospital Center NICHD CRS

The Bronx, New York, 10457, United States

Location

Jacobi Med. Ctr. Bronx NICHD CRS

The Bronx, New York, 10461, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

Philadelphia IMPAACT Unit CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Regional Med. Ctr. at Memphis

Memphis, Tennessee, 38103, United States

Location

St. Jude Children's Research Hospital CRS

Memphis, Tennessee, 38105-3678, United States

Location

Seattle Children's Research Institute CRS

Seattle, Washington, 98101, United States

Location

Hosp. General de Agudos Buenos Aires Argentina NICHD CRS

Ciudad de Buenos Aires, Buenos Aires, C1221ADC, Argentina

Location

Gaborone CRS

Gaborone, South-East District, Botswana

Location

Molepolole CRS

Gaborone, Botswana

Location

SOM Federal University Minas Gerais Brazil NICHD CRS

Belo Horizonte, Minas Gerais, 30.130-100, Brazil

Location

Hosp. Santa Casa Porto Alegre Brazil NICHD CRS

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hosp. dos Servidores Rio de Janeiro NICHD CRS

Rio de Janeiro, 20221-903, Brazil

Location

Hospital Federal dos Servidores do Estado NICHD CRS

Rio de Janeiro, 20221-903, Brazil

Location

Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS

Rio de Janeiro, 21941-612, Brazil

Location

Hosp. Geral De Nova Igaucu Brazil NICHD CRS

Rio de Janeiro, 26030, Brazil

Location

Univ. of Sao Paulo Brazil NICHD CRS

São Paulo, 14049-900, Brazil

Location

IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS

San Juan, 00935, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Wits RHI Shandukani Research Centre CRS

Johannesburg, Gauteng, 2001, South Africa

Location

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS

Cape Town, Western Cape, 7505, South Africa

Location

Famcru Crs

Tygerberg, Western Cape, 7505, South Africa

Location

Kilimanjaro Christian Medical Centre (KCMC)

Moshi, Tanzania

Location

Bhumibol Adulyadej Hosp. CRS

Sai Mai, Bangkok, 10220, Thailand

Location

Siriraj Hospital ,Mahidol University NICHD CRS

Bangkok, Bangkoknoi, 10700, Thailand

Location

Phayao Provincial Hosp. CRS

T.Tom, Muang, Changwat Phayao, 56000, Thailand

Location

Prapokklao Hosp. CRS

Chanthaburi, 22000, Thailand

Location

Chiangrai Prachanukroh Hospital NICHD CRS

Chiang Mai, 50100, Thailand

Location

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai, 50200, Thailand

Location

Chonburi Hosp. CRS

Chon Buri, 20000, Thailand

Location

Related Publications (38)

• Loutfy MR, Walmsley SL. Treatment of HIV infection in pregnant women: antiretroviral management options. Drugs. 2004;64(5):471-88. doi: 10.2165/00003495-200464050-00002.

  PMID: 14977385 BACKGROUND

• Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43(15):1071-87. doi: 10.2165/00003088-200443150-00002.

  PMID: 15568888 BACKGROUND

• Rakhmanina NY, van den Anker JN, Soldin SJ. Safety and pharmacokinetics of antiretroviral therapy during pregnancy. Ther Drug Monit. 2004 Apr;26(2):110-5. doi: 10.1097/00007691-200404000-00004.

  PMID: 15228149 BACKGROUND

• Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.

  PMID: 14562860 BACKGROUND

• Best BM, Mirochnick M, Capparelli EV, Stek A, Burchett SK, Holland DT, Read JS, Smith E, Hu C, Spector SA, Connor JD; PACTG P1026s Study Team. Impact of pregnancy on abacavir pharmacokinetics. AIDS. 2006 Feb 28;20(4):553-60. doi: 10.1097/01.aids.0000210609.52836.d1.

  PMID: 16470119 RESULT

• Stek AM, Mirochnick M, Capparelli E, Best BM, Hu C, Burchett SK, Elgie C, Holland DT, Smith E, Tuomala R, Cotter A, Read JS. Reduced lopinavir exposure during pregnancy. AIDS. 2006 Oct 3;20(15):1931-9. doi: 10.1097/01.aids.0000247114.43714.90.

  PMID: 16988514 RESULT

• Aweeka FT, Stek A, Best BM, Hu C, Holland D, Hermes A, Burchett SK, Read J, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Lopinavir protein binding in HIV-1-infected pregnant women. HIV Med. 2010 Apr;11(4):232-8. doi: 10.1111/j.1468-1293.2009.00767.x. Epub 2009 Dec 3.

  PMID: 20002783 RESULT

• Mirochnick M, Best BM, Stek AM, Capparelli EV, Hu C, Burchett SK, Rossi SS, Hawkins E, Basar M, Smith E, Read JS; IMPAACT 1026s Study Team. Atazanavir pharmacokinetics with and without tenofovir during pregnancy. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):412-9. doi: 10.1097/QAI.0b013e31820fd093.

  PMID: 21283017 RESULT

• Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, Best B, Smith E, Read JS, Watts H, Nachman S, Thorpe EM Jr, Spector SA, Jimenez E, Shearer WT, Foca M, Mirochnick M; PACTG 1026S Study Team; PACTG P1022 Study Team. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008 Apr;9(4):214-20. doi: 10.1111/j.1468-1293.2008.00553.x.

  PMID: 18366444 RESULT

• Mirochnick M, Best BM, Stek AM, Capparelli E, Hu C, Burchett SK, Holland DT, Smith E, Gaddipati S, Read JS; PACTG 1026s Study Team. Lopinavir exposure with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2008 Dec 15;49(5):485-91. doi: 10.1097/QAI.0b013e318186edd0.

  PMID: 18989231 RESULT

• Read JS, Best BM, Stek AM, Hu C, Capparelli EV, Holland DT, Burchett SK, Smith ME, Sheeran EC, Shearer WT, Febo I, Mirochnick M. Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum. HIV Med. 2008 Nov;9(10):875-82. doi: 10.1111/j.1468-1293.2008.00640.x. Epub 2008 Sep 14.

  PMID: 18795962 RESULT

• Best BM, Stek AM, Mirochnick M, Hu C, Li H, Burchett SK, Rossi SS, Smith E, Read JS, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s Study Team. Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2010 Aug;54(4):381-8. doi: 10.1097/qai.0b013e3181d6c9ed.

  PMID: 20632458 RESULT

• Stek AM, Best BM, Luo W, Capparelli E, Burchett S, Hu C, Li H, Read JS, Jennings A, Barr E, Smith E, Rossi SS, Mirochnick M. Effect of pregnancy on emtricitabine pharmacokinetics. HIV Med. 2012 Apr;13(4):226-35. doi: 10.1111/j.1468-1293.2011.00965.x. Epub 2011 Nov 30.

  PMID: 22129166 RESULT

• Cressey TR, Stek A, Capparelli E, Bowonwatanuwong C, Prommas S, Sirivatanapa P, Yuthavisuthi P, Neungton C, Huo Y, Smith E, Best BM, Mirochnick M; IMPAACT P1026s Team. Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):245-52. doi: 10.1097/QAI.0b013e31823ff052.

  PMID: 22083071 RESULT

• Cressey TR, Best BM, Achalapong J, Stek A, Wang J, Chotivanich N, Yuthavisuthi P, Suriyachai P, Prommas S, Shapiro DE, Watts DH, Smith E, Capparelli E, Kreitchmann R, Mirochnick M; IMPAACT P1026s team. Reduced indinavir exposure during pregnancy. Br J Clin Pharmacol. 2013 Sep;76(3):475-83. doi: 10.1111/bcp.12078.

  PMID: 23305215 RESULT

• Kreitchmann R, Best BM, Wang J, Stek A, Caparelli E, Watts DH, Smith E, Shapiro DE, Rossi S, Burchett SK, Hawkins E, Byroads M, Cressey TR, Mirochnick M. Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. J Acquir Immune Defic Syndr. 2013 May 1;63(1):59-66. doi: 10.1097/QAI.0b013e318289b4d2.

  PMID: 23392467 RESULT

• Watts DH, Stek A, Best BM, Wang J, Capparelli EV, Cressey TR, Aweeka F, Lizak P, Kreitchmann R, Burchett SK, Shapiro DE, Hawkins E, Smith E, Mirochnick M; IMPAACT 1026s study team. Raltegravir pharmacokinetics during pregnancy. J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):375-81. doi: 10.1097/QAI.0000000000000318.

  PMID: 25162818 RESULT

• Cressey TR, Urien S, Capparelli EV, Best BM, Buranabanjasatean S, Limtrakul A, Rawangban B, Sabsanong P, Treluyer JM, Jourdain G, Stek A, Lallemant M, Mirochnick M. Impact of body weight and missed doses on lopinavir concentrations with standard and increased lopinavir/ritonavir doses during late pregnancy. J Antimicrob Chemother. 2015 Jan;70(1):217-24. doi: 10.1093/jac/dku367. Epub 2014 Sep 25.

  PMID: 25261418 RESULT

• Aweeka FT, Hu C, Huang L, Best BM, Stek A, Lizak P, Burchett SK, Read JS, Watts H, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics. HIV Med. 2015 Mar;16(3):176-83. doi: 10.1111/hiv.12195. Epub 2014 Nov 18.

  PMID: 25407158 RESULT

• Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.

  PMID: 26202768 RESULT

• Best BM, Burchett S, Li H, Stek A, Hu C, Wang J, Hawkins E, Byroads M, Watts DH, Smith E, Fletcher CV, Capparelli EV, Mirochnick M; International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) P1026s Team. Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med. 2015 Sep;16(8):502-11. doi: 10.1111/hiv.12252. Epub 2015 May 11.

  PMID: 25959631 RESULT

• Stek A, Best BM, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, Cressey TR, Mofenson LM, Smith E, Shapiro D, Mirochnick M. Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women. J Acquir Immune Defic Syndr. 2015 Sep 1;70(1):33-41. doi: 10.1097/QAI.0000000000000668.

  PMID: 25950206 RESULT

• Tran AH, Best BM, Stek A, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, George K, Cressey TR, Chakhtoura N, Smith E, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Rilpivirine in HIV-Infected Pregnant Women. J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):289-96. doi: 10.1097/QAI.0000000000000968.

  PMID: 26918544 RESULT

• Mulligan N, Schalkwijk S, Best BM, Colbers A, Wang J, Capparelli EV, Molto J, Stek AM, Taylor G, Smith E, Hidalgo Tenorio C, Chakhtoura N, van Kasteren M, Fletcher CV, Mirochnick M, Burger D. Etravirine Pharmacokinetics in HIV-Infected Pregnant Women. Front Pharmacol. 2016 Aug 4;7:239. doi: 10.3389/fphar.2016.00239. eCollection 2016.

  PMID: 27540363 RESULT

• Mulligan N, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Buschur SL, Acosta EP, Smith E, Chakhtoura N, Burchett S, Mirochnick M; IMPAACT P1026s Protocol Team. Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV. AIDS. 2018 Mar 27;32(6):729-737. doi: 10.1097/QAD.0000000000001755.

  PMID: 29369162 RESULT

• Schalkwijk S, Ter Heine R, Colbers AC, Huitema ADR, Denti P, Dooley KE, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Mirochnick M, Burger DM. A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women. Clin Pharmacokinet. 2018 Nov;57(11):1421-1433. doi: 10.1007/s40262-018-0642-9.

  PMID: 29520730 RESULT

• Eke AC, Chakhtoura N, Kashuba A, Best BM, Sykes C, Wang J, Stek AM, Smith E, Calabrese S, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr. 2018 Jul 1;78(3):308-313. doi: 10.1097/QAI.0000000000001677.

  PMID: 29528944 RESULT

• Momper JD, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Badell ML, Acosta EP, Purswani M, Smith E, Chakhtoura N, Park K, Burchett S, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV. AIDS. 2018 Nov 13;32(17):2507-2516. doi: 10.1097/QAD.0000000000001992.

  PMID: 30134297 RESULT

• Eke AC, McCormack SA, Best BM, Stek AM, Wang J, Kreitchmann R, Shapiro D, Smith E, Mofenson LM, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum. J Clin Pharmacol. 2019 Mar;59(3):386-393. doi: 10.1002/jcph.1331. Epub 2018 Oct 25.

  PMID: 30358179 RESULT

• Kreitchmann R, Schalkwijk S, Best B, Wang J, Colbers A, Stek A, Shapiro D, Cressey T, Mirochnick M, Burger D. Efavirenz pharmacokinetics during pregnancy and infant washout. Antivir Ther. 2019;24(2):95-103. doi: 10.3851/IMP3283.

  PMID: 30530925 RESULT

• Schalkwijk S, Ter Heine R, Colbers A, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Molto J, Mirochnick M, Karlsson MO, Burger DM. Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling. J Antimicrob Chemother. 2019 May 1;74(5):1348-1356. doi: 10.1093/jac/dky567.

  PMID: 30715324 RESULT

• Liu XI, Momper JD, Rakhmanina N, van den Anker JN, Green DJ, Burckart GJ, Best BM, Mirochnick M, Capparelli EV, Dallmann A. Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir. J Clin Pharmacol. 2020 Feb;60(2):240-255. doi: 10.1002/jcph.1515. Epub 2019 Sep 6.

  PMID: 31489678 RESULT

• Eke AC, Wang J, Amin K, Shapiro DE, Stek A, Smith E, Chakhtoura N, Basar M, George K, Knapp KM, Joao EC, Rungruengthanakit K, Capparelli E, Burchett S, Mirochnick M, Best BM; P1026s Protocol Team. Fosamprenavir with Ritonavir Pharmacokinetics during Pregnancy. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02260-19. doi: 10.1128/AAC.02260-19. Print 2020 Mar 24.

  PMID: 32015036 RESULT

• Liu XI, Momper JD, Rakhmanina NY, Green DJ, Burckart GJ, Cressey TR, Mirochnick M, Best BM, van den Anker JN, Dallmann A. Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling. Clin Pharmacokinet. 2020 Nov;59(11):1433-1450. doi: 10.1007/s40262-020-00897-9.

  PMID: 32451908 RESULT

• Brooks KM, Momper JD, Pinilla M, Stek AM, Barr E, Weinberg A, Deville JG, Febo IL, Cielo M, George K, Denson K, Rungruengthanakit K, Shapiro DE, Smith E, Chakhtoura N, Rooney JF, Haubrich R, Espina R, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV. AIDS. 2021 Mar 1;35(3):407-417. doi: 10.1097/QAD.0000000000002767.

  PMID: 33252495 RESULT

• Eke AC, Shoji K, Best BM, Momper JD, Stek AM, Cressey TR, Mirochnick M, Capparelli EV. Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02168-20. doi: 10.1128/AAC.02168-20. Print 2021 Feb 17.

  PMID: 33318014 RESULT

• Momper JD, Wang J, Stek A, Shapiro DE, Scott GB, Paul ME, Febo IL, Burchett S, Smith E, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Yang DZ, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of darunavir and cobicistat in pregnant and postpartum women with HIV. AIDS. 2021 Jul 1;35(8):1191-1199. doi: 10.1097/QAD.0000000000002857.

  PMID: 34076612 RESULT

• Momper JD, Wang J, Stek A, Shapiro DE, Powis KM, Paul ME, Badell ML, Browning R, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):303-309. doi: 10.1097/QAI.0000000000002856.

  PMID: 34732682 DERIVED

Related Links

• Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
• Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; Cobicistat; Darunavir; elvitegravir; dolutegravir; Ritonavir; efavirenz; cobicistat mixture with darunavir; Lopinavir; Rifampin; Ethambutol; Isoniazid; Pyrazinamide; Kanamycin; Amikacin; Capreomycin; Moxifloxacin; Ofloxacin; Ethionamide; Prothionamide; terizidone; Cycloserine; Aminosalicylic Acid; bedaquiline; OPC-67683; Linezolid; pretomanid; Ethinyl Estradiol; etonogestrel; Nevirapine; amprenavir; abacavir; Indinavir; fosamprenavir; Emtricitabine; Tenofovir; tipranavir; Raltegravir Potassium; etravirine; Maraviroc; Rilpivirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Sulfonamides; Amides; Sulfones; Furans; Pyrimidinones; Pyrimidines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Ethylenediamines; Diamines; Polyamines; Amines; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Pyrazines; Aminoglycosides; Glycosides; Carbohydrates; Peptides, Cyclic; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Isoxazoles; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Acetamides; Acetates; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Pyrrolidinones; Pyrrolidines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Triazoles; Nitriles

Limitations and Caveats

Over the course of the study, some study arms were discontinued or closed for reasons such as there being sufficient pharmacokinetic data from other studies or lack of enrollment (as specified in Protocol Section 8.42), leading to a low number of participants in those arms. In addition, due to the COVID-19 pandemic there was a delay in running assays for certain arms and/or analyzing PK results; the results for those arms will be reported when available.

Results Point of Contact

• Title: IMPAACT Clinicaltrials.gov Coordinator
• Organization: Family Health International (FHI 360)

IMPAACT.ctgov@fstrf.org

(919) 405-1429

Study Officials

• Mark Mirochnick, MD

  Boston Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2002
• First Posted: August 1, 2002
• Study Start: June 9, 2003
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 2, 2025
• Results First Posted: July 22, 2022

Record last verified: 2025-11

Locations

PR (2); BR (7); US (39); AR (1); ZA (3); TA (1); BO (2); TH (7)