Status:
COMPLETED
Study to Improve Survival Among HIV-Exposed Infants in Botswana
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Harvard Medical School (HMS and HSDM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Neutropenia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Detailed Description
As improved MTCT prevention interventions reduce the number of HIV-infected infants in the antepartum and peripartum periods, interventions to improve HIV-free survival among HIV-uninfected infants ar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
3724 Patients enrolled
Trial Details
Trial ID
NCT01229761
Start Date
May 1 2011
End Date
October 1 2018
Last Update
September 9 2019
Active Locations (3)
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1
Princess Marina Hospital
Gaborone, Botswana
2
Athlone Hospital
Lobatse, Botswana
3
Scottish Livingstone Hospital
Molepolole, Botswana