A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
|ClinicalTrials.gov Identifier: NCT01865786|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 30, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||March 13, 2018|
|Actual Study Completion Date :||March 13, 2018|
FTC/TDF for PrEP
The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy.
The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected. This is a propensity score matched retrospective cohort selected from the prospective arm of the APR. This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865786
|United States, North Carolina|
|Antiretroviral Pregnancy Registry|
|Wilmington, North Carolina, United States, 28405|
|Study Director:||Gilead Study Director||Gilead Sciences|