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Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

NCT03499483 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-04-07

No results posted yet for this study

Summary

Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)

Conditions

  • HIV Prevention

Interventions

DRUG

bictegravir

Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.

Sponsors & Collaborators

  • Fenway Community Health

    lead OTHER

Principal Investigators

  • Kenneth H Mayer, MD · Fenway Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2020-03-30
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03499483 on ClinicalTrials.gov