Trials / Completed
CompletedNCT01865786
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 99 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2018-03-13
- Completion
- 2018-03-13
- First posted
- 2013-05-31
- Last updated
- 2018-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01865786. Inclusion in this directory is not an endorsement.