PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples

NCT02233192 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-07-07

No results posted yet for this study

Summary

The purpose of this study is to observe patient response to current clinical practice utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S. cities that are currently offering this method as standard of care. This study is an observational cohort study, which will test the feasibility and acceptability of PrEP for conception, while examining the challenges and generalizability of this current medical practice. The CDC recently released formal clinical practice guidelines for the use of PrEP in the United States. For high-risk serodiscordant heterosexual couples using PrEP during conception, the guidelines state, "PrEP use periconception and during pregnancy by the uninfected partner may offer an additional tool to reduce the risk of sexual HIV acquisition. Both the FDA labeling information and the perinatal antiretroviral treatment guidelines permit this use" (CDC 2014).

Conditions

  • PrEP for Conception Purposes

Sponsors & Collaborators

Principal Investigators

  • Margaret Sullivan, MD · Boston University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-06-15
Completion
2017-06-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233192 on ClinicalTrials.gov