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NCT04340388 · ClinicalTrials.gov registry record · Phase 4

Contribution of Dolutegravir to Obesity and Cardiovascular Disease

A Phase 4 study, sponsored by Augusta University.

Completed
Registry status
Phase 4
Development phase
10
Enrollment target

NCT04340388: Completed Phase 4 study, sponsored by Augusta University.

NCT04340388 is a Phase 4 study that has completed, run by Augusta University. 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

NCT04340388, a Phase 4 study, has completed, sponsored by Augusta University.

COMPLETED
Registry status
Phase 4
Development phase
10 participants
Enrollment target

Study Summary

The goal of the study is to combine a collaborative and translational approach to evaluate the effect antiretroviral regimen switch to a dolutegravir containing regimen compared to continued treatment with a non- dolutegravir based regimen on on lipid and metabolic profiles, renal function, body composition, vascular function and diet.

Primary Outcome

Change from baseline kilograms (kg) of weight at 24 weeks

Interventions

  • DRUG Dolutegravir 50 MG
  • DRUG Antiretroviral/Anti HIV

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-09-17
Est. Completion 2023-02-25
Phase Phase 4
Augusta University

106 total trials

What the finished NCT04340388 record still lists

NCT04340388 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 Dolutegravir 50 MG is the first listed.

NCT04340388 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04340388 about?

NCT04340388 is a clinical study titled "Contribution of Dolutegravir to Obesity and Cardiovascular Disease". The goal of the study is to combine a collaborative and translational approach to evaluate the effect antiretroviral regimen switch to a dolutegravir containing regimen compared to continued treatment with a non- dolutegravir based regimen on on lipid and metabolic profiles, renal function, body com...

What is the current status of trial NCT04340388?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2020-09-17. Estimated completion is 2023-02-25.

What interventions are being tested in trial NCT04340388?

The interventions under investigation include: Dolutegravir 50 MG (DRUG), Antiretroviral/Anti HIV (DRUG).

Who is sponsoring clinical trial NCT04340388?

This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04340388'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 NCT04340388, the US trial registry maintained by the National Library of Medicine. NCT04340388 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.