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Contribution of Dolutegravir to Obesity and Cardiovascular Disease

NCT04340388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-27

No results posted yet for this 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.

Conditions

  • HIV-1-infection
  • Antiviral Drug Adverse Reaction
  • Vascular Diseases
  • Cardiovascular Abnormalities
  • Abnormality of Adipose Tissue
  • Body Weight Changes
  • Body Fat Disorder
  • HIV-Associated Lipodystrophy Syndrome

Interventions

DRUG

Dolutegravir 50 MG

15 participants will be randomized to remain on fully suppressive background antiretroviral therapy. The third agent will be switched to dolutegravir at the dose of 50 mg daily.

DRUG

Antiretroviral/Anti HIV

15 participants with suppressed HIV disease for greater than or equal to 3 months will be randomized to remain on their current 2 or 3 drug fully suppressive antiretroviral regimen.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Jonell B Poe, MPAS · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2022-06-17
Completion
2023-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04340388 on ClinicalTrials.gov