Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the early longitudinal metabolic effects including insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed uninfected (HUU) children; as well as to determine differences in the effects of neonatal zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin sensitivity in the first 3 years of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Nevirapine; Zidovudine

Criteria

Inclusion Criteria:

• HIV-infected and uninfected pregnant women between 16-36 weeks GA are eligible for study enrollment.

• Women must be 18 years of older and able to provide informed consent for themselves and their infant to participate in the study.

• Participants must be Botswana citizens.

• Women must have evidence of HIV infection status. Women NOT documented as HIV seropositive must have documentation of HIV seronegativity during the present pregnancy at or after 32 weeks GA. Women who have an initial negative HIV test during the present pregnancy which was done at <32 weeks GA will need to undergo repeat testing on or after 32 weeks GA in accordance with national guidelines.

• HIV-uninfected women must be willing to undergo HIV pre-test counseling, rapid HIV testing and post-test counseling, referred to as HIV Testing and Counseling (HTC) during pregnancy.

• Women must be willing to remain in study area with their infant and attend scheduled study visits as described above until the child's 3rd birthday.

• For HIV-infected women, they must be on TDF/3TC or FTC/EFV or TDF/3TC or FTC/Dolutegravir at time of study enrollment or willing to initiate this treatment and continue throughout the period of breastfeeding, if not for their lifetime.

• At enrollment, all women must be willing to breastfeed exclusively for the first six months of life.

Exclusion Criteria:

•Pre-existing maternal diabetes mellitus.