Study to Improve Survival Among HIV-Exposed Infants in Botswana

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Harvard Medical School; Harvard Medical School (HMS and HSDM); National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.