Status:
COMPLETED
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infection
Eligibility:
FEMALE
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2018
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01865786
Start Date
January 1 2013
End Date
March 13 2018
Last Update
March 30 2018
Active Locations (1)
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1
Antiretroviral Pregnancy Registry
Wilmington, North Carolina, United States, 28405