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NCT01865786 Clinical Trial

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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01865786
Other study ID # GS-US-276-0101
Secondary ID
Status Completed
Phase
First received May 22, 2013
Last updated March 29, 2018
Start date January 1, 2013
Est. completion date March 13, 2018

Study information
Verified date March 2018
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date March 13, 2018
Est. primary completion date March 13, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Antiretroviral Pregnancy Registry Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP Year 1
Secondary 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
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