MedTrace Logo

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

NCT00099632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2021-11-04

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate

200mg/300mg as one tablet taken orally once daily

DRUG

Lamivudine/Zidovudine

150mg/300mg as one tablet taken orally twice daily

DRUG

Lopinavir/Ritonavir

133.3mg/33.3mg as three capsules taken orally twice daily

DRUG

single dose Nevirapine

one 200 mg tablet taken orally

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jane Hitti, MD, MPH · Department of Obstetrics/Gynecology, Perinatal Medicine, University of Washington Medical Center

  • Deborah McMahon, MD · Division of Infectious Diseases, Department of Medicine, University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-04-30
Completion
2011-11-30

Countries

  • Haiti
  • India
  • Malawi
  • South Africa
  • Tanzania
  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00099632 on ClinicalTrials.gov