This trial is active, not recruiting.

Condition hiv infection
Sponsor Gilead Sciences
Start date January 2013
End date November 2016
Trial size 400 participants
Trial identifier NCT01865786, GS-US-276-0101


This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).

Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy.
The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected. This is a propensity score matched retrospective cohort selected from the prospective arm of the APR. This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs.

Primary Outcomes

Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
time frame: Year 1

Secondary Outcomes

Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
time frame: Years 1, 2, and 3

Eligibility Criteria

Female participants of any age.

Common Inclusion Criteria - Pregnant women - Part of the prospective arm of the APR Target Group Inclusion Criteria - HIV-1 Negative - Choosing to remain on FTC/TDF for PrEP during pregnancy or, - Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria - HIV-1 Positive - On antiretroviral therapy Exclusion Criteria: - This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Additional Information

Official title A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.