Study to Improve Survival Among HIV-Exposed Infants in Botswana
Mpepu
A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana
2 other identifiers
interventional
3,724
1 country
3
Brief Summary
The purpose of this study is to find ways to improve infant health and survival among infants whose mothers are HIV-infected but who do not themselves have HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started May 2011
Longer than P75 for phase_2 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 9, 2019
September 1, 2019
3.8 years
October 22, 2010
September 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
The primary outcome measure is survival at 18 months comparing all infants in the CTX vs. placebo arms, and by randomized duration of breastfeeding among those breastfeeding at randomization.
18 months of age
Secondary Outcomes (3)
HIV-free Survival
18 months of age
Safety of CTX prophylaxis
18 months
Morbidity and mortality
18 months of age
Study Arms (4)
infant cotrimoxazole
ACTIVE COMPARATORinfant placebo
PLACEBO COMPARATORexclusive breastfeeding for 6 months
ACTIVE COMPARATORexclusive breastfeeding for 12 months
ACTIVE COMPARATORInterventions
100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months
100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months
Breastfeeding for 6 months, followed by formula feeding for 6 month. Breastfeeding infants will be prophylaxed with maternal highly active antiretroviral therapy (HAART) (if available) or with infant nevirapine.
Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.
Eligibility Criteria
You may qualify if:
- HIV-infected women, \> 26 weeks gestation and \< 34 days postpartum.
- Women must be ¬\> 18 years of age and willing/able to sign informed consent.
- Women and infants must be able to follow up regularly at a study clinic through 18 months postpartum.
- For Feeding Randomization Only: Women must be willing to breastfeed for up to 12 months, and to stop at 6 months, depending upon their feeding assignment.
You may not qualify if:
- Antepartum women: Known infant anomalies resulting in a high probability that the infant will not survive to 18 months.
- Postpartum women: Known HIV-infected infant, or infant medical condition making survival to 18 months unlikely.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Princess Marina Hospital
Gaborone, Botswana
Athlone Hospital
Lobatse, Botswana
Scottish Livingstone Hospital
Molepolole, Botswana
Related Publications (3)
Powis KM, Souda S, Lockman S, Ajibola G, Bennett K, Leidner J, Hughes MD, Moyo S, van Widenfelt E, Jibril HB, Makhema J, Essex M, Shapiro RL. Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV-exposed infants in a randomized controlled trial, Botswana. J Int AIDS Soc. 2017 Nov;20(3):e25021. doi: 10.1002/jia2.25021.
PMID: 29119726DERIVEDLockman S, Hughes M, Powis K, Ajibola G, Bennett K, Moyo S, van Widenfelt E, Leidner J, McIntosh K, Mazhani L, Makhema J, Essex M, Shapiro R. Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial. Lancet Glob Health. 2017 May;5(5):e491-e500. doi: 10.1016/S2214-109X(17)30143-2.
PMID: 28395844DERIVEDAjibola G, Zash R, Shapiro RL, Batlang O, Botebele K, Bennett K, Chilisa F, Widenfelt EV, Makhema J, Lockman S, Holmes LB, Powis KM. Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana. PLoS One. 2017 Mar 24;12(3):e0173800. doi: 10.1371/journal.pone.0173800. eCollection 2017.
PMID: 28339500DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shahin Lockman, MD, MS
Harvard School of Public Health (HSPH)
- PRINCIPAL INVESTIGATOR
Roger L Shapiro, MD, MPH
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 28, 2010
Study Start
May 1, 2011
Primary Completion
March 1, 2015
Study Completion
October 1, 2018
Last Updated
September 9, 2019
Record last verified: 2019-09