Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197587
|Study Chair:||Myron Essex, DVM,PhD||Harvard School of Public Health|