HIV Infection Clinical Trial
Official title:
Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
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.
1. 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.
2. To assess the effect of prophylactic AZT given to infants during breast feeding on HIV
transmission.
3. To confirm the safety and tolerance of one dose of NVP given to mothers and infants
4. To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
5. To determine the association between assigned infant feeding strategy and maternal
morbidity and mortality
6. 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.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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