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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01865786
First received: May 22, 2013
Last updated: February 11, 2015
Last verified: February 2015
History of Changes
  Purpose

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
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry

Resource links provided by NLM:

Drug Information available for: Truvada
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
ARV population
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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals.

All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.

Criteria

Common 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

Exclusion Criteria:

  • This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865786

Contacts
Contact: Catherine Ryan +1 (910) 679-1578 Catherine.Ryan@INCResearch.com

Locations
United States, North Carolina
Antiretroviral Pregnancy Registry Recruiting
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01865786     History of Changes
Other Study ID Numbers: GS-US-276-0101
Study First Received: May 22, 2013
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
FTC/TDF
Truvada
PrEP
Antiretroviral Pregnancy Registry

ClinicalTrials.gov processed this record on February 27, 2015