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One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

NCT00142337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2012-01-06

No results posted yet for this study

Summary

The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.

Conditions

  • HIV Infections

Interventions

DRUG

Zidovudine (ZDV)

Zidovudine 300 mg, twice daily, for one month postpartum. Note: after July 03, 2005, all women received 200 mg, twice daily, for the same duration.

DRUG

Didanosine (ddI)

250 mg ddI-EC (400 mg if body weight \>60 kg) once daily, starting at the onset of labor and for one month postpartum

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Marc Lallemant, MD · Institut de Recherche pour le Developpement

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-05-31
Completion
2009-02-28

Countries

  • Thailand

Study Locations

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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 NCT00142337 on ClinicalTrials.gov