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

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Completed
CT.gov ID
NCT00197587
Collaborator
(none)
1,200
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

  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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
May 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: maternal nevirapine

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.
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.

Outcome Measures

Primary Outcome Measures

  1. HIV PCR [1 month]

    The primary endpoint was infant HIV infection by the 1-month visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Harvard School of Public Health (HSPH)

Investigators

  • Study Chair: Myron Essex, DVM,PhD, Harvard School of Public Health (HSPH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Max Essex, Study Chair, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier:
NCT00197587
Other Study ID Numbers:
  • HSC 10411/9912BOTS
First Posted:
Sep 20, 2005
Last Update Posted:
May 20, 2013
Last Verified:
May 1, 2013
Additional relevant MeSH terms:
Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Nevirapine

Study Results

No Results Posted as of May 20, 2013