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
  Purpose

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 Intervention
HIV Infection
Infant Risk for HIV Infection by MTCT
Drug: Nevirapine
Drug: No intervention

Study Type: Interventional
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:


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

    1-month visit.



Enrollment: 1200
Study Start Date: August 2002
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197587

Sponsors and Collaborators
Harvard School of Public Health
Investigators
Study Chair: Myron Essex, DVM,PhD Harvard School of Public Health
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Max Essex, Study Chair, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197587     History of Changes
Other Study ID Numbers: HSC 10411/9912BOTS
Study First Received: September 12, 2005
Last Updated: May 17, 2013
Health Authority: Botswana: Ministry of Health
United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014