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Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand

NCT00409591 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2016-01-28

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.

Conditions

  • HIV Infections
  • Pregnancy

Interventions

DRUG

Maternal and infant nevirapine

* In women, one NVP 200 mg tablet at onset of labor; * In neonates, NVP oral suspension 6 mg in the delivery room immediately

DRUG

Maternal placebo and infant nevirapine

* In women, one placebo tablet at onset of labor; * In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours Comparison between Arms 1 and 2 is double-blinded.

DRUG

Maternal lopinavir+ritonavir

\- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

DRUG

zidovudine

In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-11-30
Completion
2015-06-30

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 NCT00409591 on ClinicalTrials.gov