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

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01865786
First received: May 22, 2013
Last updated: April 2, 2014
Last verified: April 2014

May 22, 2013
April 2, 2014
January 2013
October 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01865786 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

HIV Infection
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
October 2016
October 2016   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Catherine Ryan +1 (910) 679-1578 Catherine.Ryan@INCResearch.com
United States
 
NCT01865786
GS-US-276-0101
No
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP