At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 770 enrolled

Drug / intervention

Nevirapine and mulitvitaminsdrug

Likely dose

Nevirapine and mulitvitamins 200mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00061321

NCT00061321Phase 3Completed

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Prevention of Maternal to Infant HIV Transmission in India

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 28, 2003·Updated Jul 31, 2008

In Brief

A Phase 3 clinical trial evaluating Nevirapine and mulitvitamins for HIV Infections. Completed, enrolled 770 participants across 1 site.

Detailed Summary

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV Infections

CountriesIndia

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2002

First PostedMay 2003

Primary CompletionApr 2007

Study CompletionSep 2007

TodayJul 2026

First PostedMay 28, 2003

Enrollment StartAug 1, 2002

Primary CompletionApr 1, 2007

Study CompletionSep 1, 2007

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 23.1 years ago

Interventions

Nevirapine and mulitvitaminsdrug

Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum