A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
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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 |
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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 |
- 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 ]
- 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 |
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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.
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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.
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Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01865786
| Contact: Catherine Ryan | +1 (910) 679-1578 | Catherine.Ryan@INCResearch.com |
| United States, North Carolina | |
| Antiretroviral Pregnancy Registry | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
More Information
| 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 18, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
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FTC/TDF Truvada PrEP Antiretroviral Pregnancy Registry |
Additional relevant MeSH terms:
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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 |
ClinicalTrials.gov processed this record on September 30, 2016