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Single Dose Truvada in HIV-negative Men and Women

NCT01326221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2012-10-10

No results posted yet for this study

Summary

This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®. Concentrations of the active drug will be measured in blood (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5 days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV infectivity.

Conditions

  • Pharmacokinetic Study in Healthy Volunteers

Interventions

DRUG

tenofovir + emtricitabine

tenofovir 300mg + emtricitabine 200mg x one dose

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Angela DM Kashuba, PharmD · University of North Carolina

  • Kristine B Patterson, MD · University of North Carolina

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01326221 on ClinicalTrials.gov