Overview

Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
Female
Summary
Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
Phase:
Phase 1
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)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Treatments:
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir
Criteria
Inclusion Criteria for Mothers:

- HIV infected

- 34 weeks or more (third trimester) into pregnancy at study screening

- Have access to a participating AIDS clinical trial unit (ACTU) and are willing to be
followed at location for the duration of the study

Exclusion Criteria for Mothers:

- Prior treatment with TDF, including coformulated drugs that contain TDF, during
current pregnancy

- Active opportunistic infection and/or serious bacterial infection at time of study
entry

- Certain abnormal laboratory values at study screening

- Chronic malabsorption or chronic diarrhea

- Certain medical or obstetrical complications during the current pregnancy

- Fetal abnormalities as measured by ultrasound screening performed at 18 weeks into
pregnancy or later

- Intend to breastfeed

- Current alcohol abuse or use of illicit substances

- Participation in any other therapeutic or vaccine perinatal treatment trial during the
current pregnancy, unless given permission by the protocol chairs

- Require certain medications