Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)
This study has been completed.
Harvard School of Public Health
Information provided by (Responsible Party):
Max Essex, Harvard School of Public Health
First received: September 12, 2005
Last updated: May 17, 2013
Last verified: May 2013
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.
Infant Risk for HIV Infection by MTCT
Drug: No intervention
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Harvard School of Public Health:
Primary Outcome Measures:
- HIV PCR [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The primary endpoint was infant HIV infection by the
|Study Start Date:||August 2002|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
|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.
- 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.
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