Prevention of Milk-Borne Transmission of HIV-1C in Botswana

Study Overview
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Brief Summary
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The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.

Detailed Description
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To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to Zidovudine (ZDV, also known as AZT) as used in the Botswana mother-to-child transmission (MTCT) National Program, in reducing transmission of HIV-1 from mother to child. To determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child. To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission. To confirm the safety and tolerance of one dose of NVP given to mothers and infants To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age To determine the association between assigned infant feeding strategy and maternal morbidity and mortality To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment, among HIV+ women who previously received single dose NVP versus placebo during labour.

Official Title
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Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)

Conditions
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HIV Infection, Infant Risk for HIV Infection by MTCT

Intervention / Treatment
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* Drug: Nevirapine
* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maternal nevirapine<br> | Drug: Nevirapine<br>* All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.<br>|
| Placebo Comparator: maternal placebo<br> | Drug: No intervention<br>* All women received a background of zidovudine from 34 weeks'gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV PCR | The primary endpoint was infant HIV infection by the 1-month visit. | 1 month |