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

Completed

• Conditions: HIV Infection

• Registration Number: NCT01865786
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Status Verified: 2018-03
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Antiretroviral Pregnancy Registry; 🇺🇸 Wilmington, North Carolina, United States