A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication

Gilead Sciences

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01865786

GS-US-276-0101

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

Trial design

99 participants in 2 patient groups

FTC/TDF for PrEP

Description:

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.

ARV population

Description:

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.