Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)
Primary Purpose
HIV Infection, Infant Risk for HIV Infection by MTCT
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nevirapine
No intervention
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
maternal nevirapine
maternal placebo
Arm Description
Outcomes
Primary Outcome Measures
HIV PCR
The primary endpoint was infant HIV infection by the
1-month visit.
Secondary Outcome Measures
Full Information
NCT ID
NCT00197587
First Posted
September 12, 2005
Last Updated
May 17, 2013
Sponsor
Harvard School of Public Health (HSPH)
1. Study Identification
Unique Protocol Identification Number
NCT00197587
Brief Title
Prevention of Milk-Borne Transmission of HIV-1C in Botswana
Acronym
Mashi
Official Title
Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Infant Risk for HIV Infection by MTCT
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maternal nevirapine
Arm Type
Active Comparator
Arm Title
maternal placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
No intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV PCR
Description
The primary endpoint was infant HIV infection by the
1-month visit.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron Essex, DVM,PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16905785
Citation
Thior I, Lockman S, Smeaton LM, Shapiro RL, Wester C, Heymann SJ, Gilbert PB, Stevens L, Peter T, Kim S, van Widenfelt E, Moffat C, Ndase P, Arimi P, Kebaabetswe P, Mazonde P, Makhema J, McIntosh K, Novitsky V, Lee TH, Marlink R, Lagakos S, Essex M; Mashi Study Team. Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana: a randomized trial: the Mashi Study. JAMA. 2006 Aug 16;296(7):794-805. doi: 10.1001/jama.296.7.794.
Results Reference
result
PubMed Identifier
16816557
Citation
Shapiro RL, Thior I, Gilbert PB, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann SJ, Ndung'u T, Gaseitsiwe S, Novitsky V, Makhema J, Lagakos S, Essex M. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana. AIDS. 2006 Jun 12;20(9):1281-8. doi: 10.1097/01.aids.0000232236.26630.35.
Results Reference
result
PubMed Identifier
17215531
Citation
Lockman S, Shapiro RL, Smeaton LM, Wester C, Thior I, Stevens L, Chand F, Makhema J, Moffat C, Asmelash A, Ndase P, Arimi P, van Widenfelt E, Mazhani L, Novitsky V, Lagakos S, Essex M. Response to antiretroviral therapy after a single, peripartum dose of nevirapine. N Engl J Med. 2007 Jan 11;356(2):135-47. doi: 10.1056/NEJMoa062876.
Results Reference
result
PubMed Identifier
26684818
Citation
Powis KM, Smeaton L, Hughes MD, Tumbare EA, Souda S, Jao J, Wirth KE, Makhema J, Lockman S, Fawzi W, Essex M, Shapiro RL. In-utero triple antiretroviral exposure associated with decreased growth among HIV-exposed uninfected infants in Botswana. AIDS. 2016 Jan;30(2):211-20. doi: 10.1097/QAD.0000000000000895.
Results Reference
derived
PubMed Identifier
24086319
Citation
Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, McIntosh K, Modise TA, Asmelash A, Powis KM, Essex M, Shapiro RL, Lockman S. Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants. PLoS One. 2013 Sep 23;8(9):e74171. doi: 10.1371/journal.pone.0074171. eCollection 2013.
Results Reference
derived
PubMed Identifier
21266910
Citation
Dryden-Peterson S, Shapiro RL, Hughes MD, Powis K, Ogwu A, Moffat C, Moyo S, Makhema J, Essex M, Lockman S. Increased risk of severe infant anemia after exposure to maternal HAART, Botswana. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):428-36. doi: 10.1097/QAI.0b013e31820bd2b6.
Results Reference
derived
PubMed Identifier
21124227
Citation
Powis KM, Smeaton L, Ogwu A, Lockman S, Dryden-Peterson S, van Widenfelt E, Leidner J, Makhema J, Essex M, Shapiro RL. Effects of in utero antiretroviral exposure on longitudinal growth of HIV-exposed uninfected infants in Botswana. J Acquir Immune Defic Syndr. 2011 Feb 1;56(2):131-8. doi: 10.1097/QAI.0b013e3181ffa4f5.
Results Reference
derived
Learn more about this trial
Prevention of Milk-Borne Transmission of HIV-1C in Botswana
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