Contribution of Dolutegravir to Obesity and Cardiovascular Disease

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Abacavir; Anti-Retroviral Agents; Cobicistat; Darunavir; Dolutegravir; Lamivudine; Rilpivirine; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

Subjects must meet the following criteria to be eligible for participation in this study:

• Age greater than or equal to 18 years with HIV-1 who have been virologically suppressed (HIV-1 RNA < 50 copies for greater than or equal to 3 months on a non-integrase strand transfer inhibitor-based regimen

• Have the ability to understand and sign an informed consent written in the English language

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria are not to be enrolled in this study:

• Age less than 18 years without HIV-1 infection

• Has hypersensitivity or other contraindication to any of the components of the study

• Has active diagnosis of untreated hepatitis due to any cause

• Has a history or current evidence of any condition, laboratory abnormality or other circumstance ( including drug or alcohol use or dependence) that might confound the results of the study or interfere with the subject's participation for the full duration of the study

• Is taking or is anticipated to require long term systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 60 days prior to Screening/Day 1 visit through to the end of study

• Has documented or suspected dolutegravir-associated resistance mutations specifically:

Q148H/K/R/N in combination with E138K or G1402/A or N155H.

• Has a life expectancy less than or equal to one year

• Is pregnant, breastfeeding, or expecting to donate eggs or sperm or conceive or father a child at any time during the study and 6 weeks following the end of study.