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

NCT01865786 | Completed

• 1 other identifier: GS-US-276-0101
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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 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

HIV Infection

Keywords

FTC/TDF; Truvada; PrEP; Antiretroviral Pregnancy Registry

Outcome Measures

Primary Outcomes (1)

• Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP

  Year 1

Secondary Outcomes (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

  Years 1, 2, and 3

Study Arms (2)

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 Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women
• HIV-1 Negative
• Choosing to remain on FTC/TDF for PrEP during pregnancy or,
• HIV-1 Positive
• On antiretroviral therapy

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Antiretroviral Pregnancy Registry

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2013
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

US (1)