Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
This study has been completed.
Sponsor:
Harvard School of Public Health
Information provided by (Responsible Party):
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197587
First received: September 12, 2005
Last updated: April 20, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Detailed Description:
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Nevirapine
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
1-month visit.
Enrollment: | 1200 |
Study Start Date: | August 2002 |
Primary Completion Date: | April 2008 (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:
- 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.
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
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | 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: | April 20, 2012 |
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 October 16, 2012