Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda

NCT00639938 | Completed Phase 3 DMC

• 1 other identifier: R01AI034235
• Study Type: interventional
• Target: 722
• Locations: 0 countries
• Sites: N/A

Brief Summary

The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV transmissions in developing countries occur in late pregnancy or during labor and delivery. Interventions targeted during the perinatal period have shown to be effective and to have a significant impact in reducing transmission. The purpose of this study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or extended NVP dosing regimens in HIV-infected pregnant women and their infants during the perinatal period.

Conditions

HIV Infections

Keywords

Pregnancy, High-Risk; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Rate of HIV infection in infants born to study participants in each arm of the study

  At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18

• Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone

  Throughout study

Secondary Outcomes (4)

• Rate of immunologic progression in HIV-infected infants in each arm

  Throughout study

• Infant mortality

  Throughout study

• Maternal plasma HIV RNA levels at delivery

  At Birth

• Immunologic, virologic, and pharmacologic factors

  Throughout study

Study Arms (3)

1

ACTIVE COMPARATOR

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor Infant dosing regimen: Single dose of 2 mg/kg NVP taken orally within the first week after delivery

Drug: Nevirapine

2

EXPERIMENTAL

Mother dosing regimen: Single dose of 200 mg NVP taken orally at onset of labor Infant dosing regimen: 2 mg/kg NVP taken orally within the first week after delivery and 5 mg NVP taken orally daily from Day 8 through Week 6

Drug: Nevirapine

3

EXPERIMENTAL

Mother dosing regimen: Single 12 gm intravenous dose of HIVIGLOB at 36 - 37 weeks gestation and 200 mg NVP taken orally at onset of labor Infant dosing regimen: Single 1.2 gm intravenous dose HIVIGLOB within 18 hours of birth and 2 mg/kg NVP taken orally within the first week after delivery

Drug: Nevirapine; Drug: HIV immune globulin solution

Interventions

Nevirapine DRUG

200 mg Nevirapine tablet

Also known as: NVP Viramune

1; 2; 3

HIV immune globulin solution DRUG

5% intravenous HIV immune globulin solution

Also known as: HIVIGLOB

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant between 32-36 weeks estimated gestation
• HIV Infected
• Intent to breastfeed infant
• Certain laboratory criteria. More information on this criterion can be found in the protocol.

You may not qualify if:

• Sensitivity to immune globulin preparations or any benzodiazepine
• Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements
• Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)
• Participation in any HIV vaccine trials
• History of cytotoxic chemotherapy within one month of study entry
• Uncontrolled hypertension
• Chronic alcohol or illicit drug use
• History of non-compliance with visits or medication
• Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial

Sponsors & Collaborators

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

Related Publications (5)

• Colvin M, Chopra M, Doherty T, Jackson D, Levin J, Willumsen J, Goga A, Moodley P; Good Start Study Group. Operational effectiveness of single-dose nevirapine in preventing mother-to-child transmission of HIV. Bull World Health Organ. 2007 Jun;85(6):466-73. doi: 10.2471/blt.06.033639.

  PMID: 17639244 BACKGROUND

• Flys TS, Mwatha A, Guay LA, Nakabiito C, Donnell D, Musoke P, Mmiro F, Jackson JB, Eshleman SH. Detection of K103N in Ugandan women after repeated exposure to single dose nevirapine. AIDS. 2007 Oct 1;21(15):2077-82. doi: 10.1097/QAD.0b013e3282703847.

  PMID: 17885298 BACKGROUND

• Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Owor M, Ducar C, Deseyve M, Mwatha A, Emel L, Duefield C, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Gigliotti M, Bray D, Mmiro F. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003 Sep 13;362(9387):859-68. doi: 10.1016/S0140-6736(03)14341-3.

  PMID: 13678973 BACKGROUND

• Onyango-Makumbi C, Omer SB, Mubiru M, Moulton LH, Nakabiito C, Musoke P, Mmiro F, Zwerski S, Wigzell H, Falksveden L, Wahren B, Antelman G, Fowler MG, Guay L, Jackson JB. Safety and efficacy of HIV hyperimmune globulin for prevention of mother-to-child HIV transmission in HIV-1-infected pregnant women and their infants in Kampala, Uganda (HIVIGLOB/NVP STUDY). J Acquir Immune Defic Syndr. 2011 Dec 1;58(4):399-407. doi: 10.1097/QAI.0b013e31822f8914.

  PMID: 21826009 DERIVED

• Six Week Extended-Dose Nevirapine (SWEN) Study Team; Bedri A, Gudetta B, Isehak A, Kumbi S, Lulseged S, Mengistu Y, Bhore AV, Bhosale R, Varadhrajan V, Gupte N, Sastry J, Suryavanshi N, Tripathy S, Mmiro F, Mubiru M, Onyango C, Taylor A, Musoke P, Nakabiito C, Abashawl A, Adamu R, Antelman G, Bollinger RC, Bright P, Chaudhary MA, Coberly J, Guay L, Fowler MG, Gupta A, Hassen E, Jackson JB, Moulton LH, Nayak U, Omer SB, Propper L, Ram M, Rexroad V, Ruff AJ, Shankar A, Zwerski S. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet. 2008 Jul 26;372(9635):300-13. doi: 10.1016/S0140-6736(08)61114-9.

  PMID: 18657709 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

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

Study Officials

• Brooks Jackson, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 20, 2008
• Study Start: July 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 2, 2008

Record last verified: 2008-03