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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Max Essex, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197587
First received: September 12, 2005
Last updated: May 17, 2013
Last verified: May 2013

September 12, 2005
May 17, 2013
August 2002
May 2005   (final data collection date for primary outcome measure)
HIV PCR [ Time Frame: 1 month ] [ Designated as safety issue: No ]

The primary endpoint was infant HIV infection by the

1-month visit.

Not Provided
Complete list of historical versions of study NCT00197587 on ClinicalTrials.gov Archive Site
Not Provided
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Prevention of Milk-Borne Transmission of HIV-1C in Botswana
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infection
  • Infant Risk for HIV Infection by MTCT
  • Drug: 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.
  • 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.
  • Active Comparator: maternal nevirapine
    Intervention: Drug: Nevirapine
  • Placebo Comparator: maternal placebo
    Intervention: Drug: No intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
Not Provided
May 2005   (final data collection date for primary outcome measure)

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.
Female
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00197587
HSC 10411/9912BOTS
Yes
Max Essex, Harvard School of Public Health
Harvard School of Public Health
Not Provided
Study Chair: Myron Essex, DVM,PhD Harvard School of Public Health
Harvard School of Public Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP