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NCT03499483 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Fenway Community Health.

Completed
Registry status
Phase 4
Development phase
52
Enrollment target

NCT03499483: Completed Phase 4 study, sponsored by Fenway Community Health.

NCT03499483 is a Phase 4 study that has completed, run by Fenway Community Health. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03499483, a Phase 4 study, has completed, sponsored by Fenway Community Health.

COMPLETED
Registry status
Phase 4
Development phase
52 participants
Enrollment target

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)

Primary Outcome

HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.

Interventions

  • DRUG bictegravir

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2019-01-24
Est. Completion 2020-03-31
Phase Phase 4
Fenway Community Health

14 total trials

What the finished NCT03499483 record still lists

NCT03499483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which bictegravir is the first listed.

NCT03499483 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03499483 about?

NCT03499483 is a clinical study titled "Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)". 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)

What is the current status of trial NCT03499483?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2019-01-24. Estimated completion is 2020-03-31.

What interventions are being tested in trial NCT03499483?

The interventions under investigation include: bictegravir (DRUG).

Who is sponsoring clinical trial NCT03499483?

This trial is sponsored by Fenway Community Health, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03499483's enrollment target sits among peer trials

52 1233rd of 2000 higher than 752 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03499483, the US trial registry maintained by the National Library of Medicine. NCT03499483 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.