More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

NCT03497676 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: IMPAACT 201730070
• Study Type: interventional
• Target: 168
• Locations: 5 countries
• Sites: 19

Brief Summary

The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (28)

• Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 4

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 4

• Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)

  Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 4

• Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 4

• Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 4

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 16

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 16

• Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)

  Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 16

• Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 16

• Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

  We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 1 Treatment Initiation through Week 16

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 2 Treatment Initiation through Week 24

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)

  Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 2 Treatment Initiation through Week 24

• Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2)

  Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 2 Treatment Initiation through Week 24

• Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)

  We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 2 Treatment Initiation through Week 24

• Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)

  We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).

  Cohort 2 Treatment Initiation through Week 24

• Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)

  AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.

  Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

• Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)

  We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.

  Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose

• Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)

  We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples

  Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose

• Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)

  We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.

  Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

• Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C)

  We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.

  Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose

• Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)

  We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.

  Week 16

• Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W)

  We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.

  Samples collected at Weeks 4b, 5, 6, and 8

• Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W)

  We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.

  Samples collected at Weeks 4b, 5, 6, 8

• Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)

  We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.

  Week 4b, Week 8, Week 12

• Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)

  We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.

  Week 16

• Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W)

  We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.

  Samples collected at Weeks 4b, 5, and 8

• Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W)

  We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.

  Samples collected at Weeks 4b, 5, and 8

• Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)

  We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.

  Week 4b, Week 8

Secondary Outcomes (17)

• Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1)

  Week 16

• Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1)

  Week 8

• Median Dimension of Quality of Life Scores

  Week 16

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)

  Cohort 2 treatment initiation through Week 48

• Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)

  Cohort 2 treatment initiation through Week 48

Study Arms (4)

Cohort 1C: CAB

EXPERIMENTAL

Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).

Drug: Oral Cabotegravir (CAB); Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Combination Antiretroviral Therapy (cART)

Cohort 1R: RPV

EXPERIMENTAL

Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).

Drug: Oral Rilpivirine (RPV); Drug: Long-Acting Injectable Rilpivirine (RPV LA); Drug: Combination Antiretroviral Therapy (cART)

Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

EXPERIMENTAL

Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.

Drug: Oral Cabotegravir (CAB); Drug: Oral Rilpivirine (RPV); Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Long-Acting Injectable Rilpivirine (RPV LA)

Cohort 2B: CAB LA + RPV LA

EXPERIMENTAL

Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit.

Drug: Long-Acting Injectable Cabotegravir (CAB LA); Drug: Long-Acting Injectable Rilpivirine (RPV LA)

Interventions

Long-Acting Injectable Rilpivirine (RPV LA) DRUG

Administered by intramuscular (IM) injection

Cohort 1R: RPV; Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA; Cohort 2B: CAB LA + RPV LA

Combination Antiretroviral Therapy (cART) DRUG

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.

Cohort 1C: CAB; Cohort 1R: RPV

Oral Rilpivirine (RPV) DRUG

25 mg tablets administered orally

Also known as: Edurant

Cohort 1R: RPV; Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Oral Cabotegravir (CAB) DRUG

30 mg tablets administered orally

Cohort 1C: CAB; Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA

Long-Acting Injectable Cabotegravir (CAB LA) DRUG

Administered by intramuscular (IM) injection

Cohort 1C: CAB; Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA; Cohort 2B: CAB LA + RPV LA

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At enrollment, body weight greater than or equal to 35 kg (77 lbs)
• For Cohort 1, at enrollment, body mass index (BMI) less than or equal to 31.5 kg/m\^2
• At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee
• Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol.
• For at least 3 consecutive months (defined as 90 consecutive days) prior to screening, and prior to enrollment, has been on stable unchanged cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
• Note: Participants undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable cART.
• Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected 6 to 12 months (defined as 180 to 365 days) prior to entry. OR
• Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected less than 6 months (defined as within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (defined as 365 to 545 days) prior to entry.
• For Cohort 1 participants enrolling to Cohort 2, has documented plasma HIV-1 RNA results less than the lower limit of detection of the assay from all indicated Cohort 1 study visits with their Cohort 1 Week 16 visit completed within 28 days prior to Cohort 2 entry.
• At screening, has Grade 2 or lower of all the following laboratory test results:
• Alanine transaminase (ALT) (u/l)
• Lipase (u/l)
• Estimated creatinine clearance (CrCl; Schwartz formula mL/min/1.73m\^2)
• Platelets (cells/mm\^3)
• Hemoglobin (g/dL)

You may not qualify if:

• Adolescents will be excluded from the study if any of the following are identified during the screening period:
• Within 6 months (defined as within 179 days) prior to entry, two consecutive documented HIV-1 RNA values greater than the lower limit of detection of the assay
• For Cohort 1 participants enrolling to Cohort 2, Step 3, occurrence of any Grade 3 or higher adverse event assessed as related to study product or permanent discontinuation of study product due to an adverse event of any grade assessed as related to study product during participation in Cohort 1 (including any long-term safety and washout PK follow-up visits).
• For participants enrolling to Cohort 1 Step 1, based on available medical records, currently on either a cART regimen containing both a protease inhibitor (PI) and an integrase strand transfer inhibitor (INSTI), or a cART regimen containing both an INSTI and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
• As determined by the IoR or designee, and based on available medical records, known or suspected resistance to RPV
• As determined by the IoR or designee based on available medical records, known or suspected resistance to INSTIs
• History of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease, as determined by the IoR or designee based on available medical records
• At entry, known active tuberculosis infection, requiring anti-tuberculosis treatment, as determined by the IoR or designee based on available medical records
• Known hepatitis B or hepatitis C infection, as determined by the IoR or designee based on available medical records
• Clinically significant hepatic disease, as determined by the IoR or designee based on available medical records
• Current or anticipated need for chronic anti-coagulation, as determined by the IoR or designee, based on available medical records
• History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records
• History of known or suspected bleeding disorder including history of prolonged bleeding, as determined by the IoR or designee, based on available medical records
• Known or suspected allergy to study product components
• More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, based on available medical records.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• ViiV Healthcare: collaborator

Study Sites (19)

Usc La Nichd Crs

Los Angeles, California, 90089, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 80045, United States

Location

Pediatric Perinatal HIV NICHD CRS, Site 5127

Miami, Florida, 33136, United States

Location

Emory University School of Medicine NICHD CRS

Atlanta, Georgia, 30322, United States

Location

Lurie Children's Hospital of Chicago (LCH) CRS

Chicago, Illinois, 60614-3393, United States

Location

Johns Hopkins Univ. Baltimore NICHD CRS

Baltimore, Maryland, 21287, United States

Location

St. Jude Children's Research Hospital CRS

Memphis, Tennessee, 38105-3678, United States

Location

Baylor College of Medicine/ Texas Children's Hospital NICHD CRS

Houston, Texas, 77030, United States

Location

Gaborone CRS

Gaborone, South-East District, Botswana

Location

Molepolole CRS, Site 12702

Molepolole, Botswana

Location

Famcru Crs

Tygerberg Hills, Western Cape, 7505, South Africa

Location

Wits RHI Shandukani Research Centre CRS

Johannesburg, 2001, South Africa

Location

Soweto CRS, Site 8052

Soweto, 1862, South Africa

Location

Umlazi CRS

Umlazi, 4066, South Africa

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, 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

Baylor-Uganda CRS

Kampala, 72052, Uganda

Location

MU-JHU Care Limited CRS

Kampala, Uganda

Location

Related Publications (6)

• Gaur AH, Capparelli EV, Calabrese K, Baltrusaitis K, Marzinke MA, McCoig C, Van Solingen-Ristea RM, Mathiba SR, Adeyeye A, Moye JH, Heckman B, Lowenthal ED, Ward S, Milligan R, Samson P, Best BM, Harrington CM, Ford SL, Huang J, Crauwels H, Vandermeulen K, Agwu AL, Smith-Anderson C, Camacho-Gonzalez A, Ounchanum P, Kneebone JL, Townley E, Bolton Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2024 Apr;11(4):e211-e221. doi: 10.1016/S2352-3018(23)00300-4.

  PMID: 38538160 RESULT

• Lowenthal ED, Chapman J, Ohrenschall R, Calabrese K, Baltrusaitis K, Heckman B, Yin DE, Agwu AL, Harrington C, Van Solingen-Ristea RM, McCoig CC, Adeyeye A, Kneebone J, Chounta V, Smith-Anderson C, Camacho-Gonzalez A, D'Angelo J, Bearden A, Crauwels H, Huang J, Buisson S, Milligan R, Ward S, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study. Lancet HIV. 2024 Apr;11(4):e222-e232. doi: 10.1016/S2352-3018(23)00301-6.

  PMID: 38538161 RESULT

• Gaur AH, Baltrusaitis K, Capparelli EV, Moye JH, Yin DE, Masheto G, Buisson S, Harrington CM, Marzinke MA, Lowenthal ED, Scheckter R, Ace A, Ward S, Milligan R, Whitson K, Huang J, Cheung SYA, Best BM, Townley E, Roberts G, Kakuda TN, Birmingham E, Mathiba SR, Aurpibul L, Korutaro V, Smith C, Patel F, Moodley E, Bolton-Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. Lancet HIV. 2026 Feb;13(2):e85-e94. doi: 10.1016/S2352-3018(25)00242-5. Epub 2026 Jan 14.

  PMID: 41547359 DERIVED

• Lowenthal ED, Chapman J, Baltrusaitis K, Kovic G, Merchant S, Branch K, Tsosie C, Vaca MZ, Heckman B, Van Solingen-Ristea RM, Harrington CM, Yin DE, Townley E, Whitton M, Agwu AL, Smith C, Paul ME, Violari A, Moodley E, Owor M, Chokephaibulkit K, Fry S, Jao J, Mitchell CD, Buisson S, Ace A, Kolobova I, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. Lancet HIV. 2026 Feb;13(2):e95-e103. doi: 10.1016/S2352-3018(25)00241-3. Epub 2026 Jan 14.

  PMID: 41547358 DERIVED

• Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.

  PMID: 40655875 DERIVED

• Moore CB, Baltrusaitis K, Best BM, Moye JH, Townley E, Violari A, Heckman B, Buisson S, Van Solingen-Ristea RM, Capparelli EV, Marzinke MA, Lowenthal ED, Ward S, Krotje C, Milligan R, Agwu AL, Huang J, Cheung SYA, McCoig C, Yin DE, Roberts G, Crauwels H, Van Eygen V, Zabih S, Masheto G, Ounchanum P, Aurpibul L, Korutaro V, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2025 Mar;12(3):e191-e200. doi: 10.1016/S2352-3018(24)00344-8.

  PMID: 40049924 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
• ICH Criteria for Meeting Serious Adverse Events

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Rilpivirine; Antiretroviral Therapy, Highly Active

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)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Therapy, Combination; Drug Therapy; Therapeutics

Results Point of Contact

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

IMPAACT.ctgov@fstrf.org

(919) 405-1429

Study Officials

• Carolyn Bolton Moore, MSc, MBBCh

  Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham

  STUDY CHAIR

• Aditya H. Gaur, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: April 3, 2019
• Primary Completion: February 18, 2023
• Study Completion: April 22, 2025
• Last Updated: January 28, 2026
• Results First Posted: May 14, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• Access Criteria: * With whom? * Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. * For what types of analyses? * To achieve aims in the proposal approved by the IMPAACT Network. * By what mechanism will data be made available? * Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

TH (3); US (8); ZA (4); UG (2); BO (2)