A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
This trial is active, not recruiting.
|Start date||January 2013|
|End date||January 2017|
|Trial size||400 participants|
|Trial identifier||NCT01865786, GS-US-276-0101|
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.
Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
time frame: Year 1
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
time frame: Years 1, 2, and 3
Female participants of any age.
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.
|Official title||A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry|
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