A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry

Gilead Sciences1 site in 1 country99 target enrollmentJanuary 1, 2013

ConditionsHIV Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infection
Sponsor: Gilead Sciences
Enrollment: 99
Locations: 1
Primary Endpoint: Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

March 13, 2018

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

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.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

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(Years 1, 2, and 3)