Clinical trialNCT00099632CompletedPhase 2Interventional

Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment484HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared. The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Deborah McMahon, MD
Division of Infectious Diseases, Department of Medicine, University of Pittsburgh
Study Chair
clinicaltrials.gov ↗
Jane Hitti, MD, MPH
Department of Obstetrics/Gynecology, Perinatal Medicine, University of Washington Medical Center
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Haiti

Les Centres Gheskio Clinical Research Site (gheskio-Inlr) Crs
Port-au-Prince, Haiti

India

Byramjee Jeejeebhoy Government Medical College Crs
Pune, Maharashtra, India
Chennai Antiviral Research and Treatment (cart) Crs
Chennai, Tamil Nadu, India

Malawi

Blantyre Crs
Blantyre, Malawi

South Africa

Wits Helen Joseph Hospital Crs (wits Hjh Crs)
Johannesburg, Gauteng, South Africa
Durban International Crs
Westville, KwaZulu-Natal, South Africa

Tanzania

Kilimanjaro Christian Medical Crs
Moshi, Tanzania

Uganda

Joint Clinical Research Center (jcrc)/kampala Crs
Kampala, Uganda

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Emtricitabine →Lamivudine →Lopinavir →Single dose Nevirapine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2006
Primary completion: 30 Apr 2010
Completion: 30 Nov 2011
Last update posted: 4 Nov 2021
Registered enrollment: 484
Registry id: NCT00099632

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.