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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01865786

Enrollment

Registered

2013-05-31

Start date

2013-01-01

Completion date

2018-03-13

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

FTC/TDF, Truvada, PrEP, Antiretroviral Pregnancy Registry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results