Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)
|ClinicalTrials.gov Identifier: NCT00197587|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Infant Risk for HIV Infection by MTCT||Drug: Nevirapine Drug: No intervention||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||May 2005|
|Active Comparator: maternal nevirapine||
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.
|Placebo Comparator: maternal placebo||
Drug: No intervention
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.
- HIV PCR [ Time Frame: 1 month ]
The primary endpoint was infant HIV infection by the
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197587
|Study Chair:||Myron Essex, DVM,PhD||Harvard School of Public Health|