Status:
COMPLETED
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
Lead Sponsor:
Augusta University
Conditions:
HIV-1-infection
Antiviral Drug Adverse Reaction
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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...
Detailed Description
Over the last decades, the use of combined antiretroviral therapy has led to profound suppression of HIV-1 replication and increased the survival of persons living with HIV (PLWH) to close to that of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04340388
Start Date
September 17 2020
End Date
February 25 2023
Last Update
July 27 2023
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912