Title: Phase III Trial To Determine The Efficacy And Safety Of An Extended Regimen Of Nevirapine In Infants Born To HIV-Infected Women To Prevent Mother To Child HIV Transmission During Breastfeeding (HPTN 046)

Sponsor: Division of AIDS, US National Institute of Allergy and Infectious Diseases

Principal Investigators

Zimbabwe :

Professor Tsungai Chipato 
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USA :

Prof Yvonne Maldonado 
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Prof Avinash K Shetty 
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Study Summary

The aim of the study is to evaluate the efficacy and safety of an extended regimen of nevirapine (NVP) provided for six months or through cessation of breastfeeding, whichever is earliest, compared to NVP placebo, for prevention of mother-to-child transmission (PMTCT) in infants who are born to HIV-infected women and are breastfeeding.

This is a multi-site study being carried out in Zimbabwe, Uganda, South Africa and Tanzania.  The total enrolment across all sites was set at 1670 participants, with about 512 mother-infant pairs having been enrolled from Zimbabwe.

The Zimbabwe site operates from 2 research clinics, namely Seke North and Saint Mary's in Chitungwiza. The first participant at this site was enrolled in March 2007, with the first protocol refresher training held on Friday 21st November 2008. The Study screened a total of 666 women and  enrolled 512 mother-infant pairs in total.

Throught the first 6 weeks of life all enrolled participants were given active Nevirapine. Participants were  then randomized into 2 arms: active nevirapine or placebo daily through 6 months of life, on or after 30 days post cessation of breastfeeding whichever came first. The study is double blinded and placebo controlled.  Each participant is followed up at 2, 4 and 6 weeks, 3, 4, 5, 6, 9, 12, 15 and 18 months of life to monitor safety and to check for HIV infection. 

Latest on 046 

The HPTN O46 Study stopped screening on 29 December 2009, as the required sample size for the study has been screened. Enrolment to the study was completed on 21 January 2010. Currently the study is focusing on rentention and follow up of the enrolled participants. Enrolled infants will continue in the follow up through 18 months of age.The intervantion period is expected to end mid-July 2010.

Study Contacts

1. Lynda Stranix-Chibanda (Project Director/Paediatrician of Record) 
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