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NCT04249037 · ClinicalTrials.gov registry record · Phase 4

Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

A Phase 4 study, sponsored by University of Colorado, Denver.

Terminated
Registry status
Phase 4
Development phase
10
Enrollment target

NCT04249037: Clinical Trial Phase 4 study, sponsored by University of Colorado, Denver.

NCT04249037 is a Phase 4 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04249037, a Phase 4 study, was terminated before completion, sponsored by University of Colorado, Denver.

TERMINATED
Registry status
Phase 4
Development phase
10 participants
Enrollment target

Study Summary

This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

Primary Outcome

Proportion of participants with viral suppression to \<50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm.

Interventions

  • DRUG bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
  • DRUG Standard initiation of antiretroviral therapy (ART)

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-12-15
Est. Completion 2023-07-01
Phase Phase 4
University of Colorado, Denver

1,283 total trials

Why NCT04249037 stopped before completion

NCT04249037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) is the first listed.

NCT04249037 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04249037 about?

NCT04249037 is a clinical study titled "Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV". This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

What is the current status of trial NCT04249037?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2020-12-15. Estimated completion is 2023-07-01.

What interventions are being tested in trial NCT04249037?

The interventions under investigation include: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) (DRUG), Standard initiation of antiretroviral therapy (ART) (DRUG).

Who is sponsoring clinical trial NCT04249037?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04249037's enrollment target sits among peer trials

10 1940th of 2000 higher than 33 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 NCT04249037, the US trial registry maintained by the National Library of Medicine. NCT04249037 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.