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

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ClinicalTrials.gov Identifier: NCT01865786
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infection

Study Design

Study Type : Observational
Actual Enrollment : 99 participants
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
Actual Study Start Date : January 1, 2013
Primary Completion Date : January 31, 2017
Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada
U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :
  1. Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP [ Time Frame: Year 1 ]

Secondary Outcome Measures :
  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 [ Time Frame: Years 1, 2, and 3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.


Key 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

Key Exclusion Criteria:

  • This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865786

United States, North Carolina
Antiretroviral Pregnancy Registry
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Gilead Sciences
Study Director: Gilead Study Director Gilead Sciences
More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01865786     History of Changes
Other Study ID Numbers: GS-US-276-0101
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Gilead Sciences:
Antiretroviral Pregnancy Registry

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents