Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead Sciences
• Treatments: Tenofovir

Criteria

Antepartum (AP) Part of Study (TDF Exposure During Pregnancy)

Inclusion Criteria:

• Mother-infant pair enrolled in 1077BA or 1077FA

• At a clinical site that has been approved as a P1084s DXA site

• Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days after 1077BA/1077FA study entry) and prior to the start of labor

• Willing and able to provide written informed consent to participate in this substudy

Exclusion Criteria:

• None

Postpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)

Inclusion Criteria:

• Mother and their infant enrolled in 1077BP

• At a clinical site that has been approved as a P1084s DXA site

• Enrolled in the substudy within 6 to 14 days of delivery, on the same day as enrollment in 1077BP

• Willing and able to provide written informed consent to participate in this substudy

Exclusion Criteria:

• TDF exposure during pregnancy [NOTE: TDF use for up to 12 days beginning at labor allowed]

• Enrolled in the AP part of P1084s