Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Collaborators: Fogarty International Center of the National Institute of Health; Harvard Initiative for Global Health; John E. Fogarty International Center (FIC); National Institute of Allergy and Infectious Diseases (NIAID); The American Society of Tropical Medicine and Hygiene
• Treatments: Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Both maternal and infant criteria need to be met:

Maternal Inclusion Criteria:

• documented HIV infection

• taking 3-drug highly active antiretroviral therapy at any point during pregnancy (note: can include 2 NRTI+NNRTI, 2NRTI+PI, or 3 NRTI)

• 21 years of age or older, and able and willing to sign informed consent

• Proof of Botswana Citizenship

Maternal Exclusion Criteria:

• involuntary incarceration

Infant Inclusion Criteria:

• younger than 42 days of age

• able to be brought to regular visits at study clinic until at least 6 months postpartum

Infant Exclusion Criteria:

• known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months

• known hypersensitivity to cotrimoxazole