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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:January 1, 2013
End Date:March 13, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
1
site
Antiretroviral Pregnancy Registry
Wilmington, North Carolina 28405
?
mi
from
Wilmington, NC
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