A Phase 4 interventional study of Dolutegravir 50 MG and Antiretroviral/Anti HIV in HIV-1-infection, Antiviral Drug Adverse Reaction and Vascular Diseases, sponsored by Augusta University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Augusta University · Phase 4, Interventional, and Basic science
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.
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 the general population. As a consequence, the spectrum of diseases related to HIV has shifted from opportunistic AIDS-related diseases towards long-term-age-related complications. Individuals living with HIV are now exhibiting accelerated development of obesity, metabolic derangements and cardiovascular disease (CVD). Recent compelling clinical evidence has documented a drastic shift in anthropometric profiles among persons living with HIV. In addition, several reports present dolutegravir, a second-generation integrase inhibitor currently highly prescribed for its high antiviral efficiency, as the potential cause of unpredicted weight gain. A critical gap in the investigators' knowledge is a lack of understanding of the etiopathology of the contribution of dolutegravir on weight gain and the consequential impact on obesity and cardiovascular disease in persons living with HIV on combined antiretroviral therapy. As overweight and obesity are among the leading risk factors for cardiovascular disease in persons living with HIV, it is critical to directly investigate whether dolutegravir increases fat mass in persons living with HIV and whether body weight gains-associated with dolutegravir based regimen contribute to the increased prevalence of CVD in this population of people.
This application seeks to investigate alterations in body fat and cardiometabolic risk markers associated with dolutegravir. The investigators propose that in patients with undetectable plasma HIV RNA, there is a direct correlation of weight gain and dolutegravir after antiretroviral regimen switch. They also contend that dolutegravir associated weight gain induces a phenotypic metabolic shift which alters the vascular endothelium and potentiates CVD risk. If the investigators are correct in their hypotheses, modifications in the clinical practice of treatment and prevention strategies for CVD in people living with HIV may be warranted.
Herein the investigators propose a novel translational study which will concomitantly investigate in human patients and animal models of HIV:
694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.
This study's enrollment of 10 is below the median of 96 across 419 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Subjects must meet the following criteria to be eligible for participation in this study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria are not to be enrolled in this study:
Q148H/K/R/N in combination with E138K or G1402/A or N155H.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with HIV-1 infection who have had viral suppression on a non-integrase based antiretroviral regimen for greater than or equal to 3 months will be switched to a dolutegravir based regimen dosed at 50 milligrams (MG) once daily. Background regimen will remain the same.
Drug: Dolutegravir 50 MG
Participants not currently on an integrase based regimen who remain on current suppressive therapy will remain on current antiretroviral regimen.
Drug: Antiretroviral/Anti HIV
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.
Also known as: Tenofovir alafenamide, Tenofovir disoproxil fumarate, Abacavir, Lamivudine, Darunavir, Cobicistat, Rilpivirine, Combivir, Zidovudine
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.
Also known as: Antiretroviral Combinations
Change in Weight
Change from baseline kilograms (kg) of weight at 24 weeks
Time frame: 24 weeks
Change in body mass index (BMI)
Total change in body mass index -height and weight will be combined to report BMI (Kilogram/Height in centimeters\^2)
Time frame: 24 weeks
Change in vascular endothelial function
Change from baseline vessel diameter (millimeters) at 24 weeks
Time frame: 24 weeks
Height
Measurement of height (centimeters) from baseline to 24 weeks
Time frame: 24 weeks
Change in cholesterol
Change from baseline cholesterol (mg/dL) at 24 weeks
Time frame: 24 weeks
Change in triglycerides
Change from baseline triglycerides (mg/dL) at 24 weeks
Time frame: 24 weeks
Change in high density lipoprotein (HDL)
Change from baseline HDL (mg/dL) at 24 weeks
Time frame: 24 weeks
Change in low density lipoprotein (LDL)
Change from baseline LDL (mg/dL) at 24 weeks
Time frame: 24 weeks
Change in HIV-1 RNA viral load
Change from baseline HIV-1 viral load (copies) at 24 weeks
Time frame: 24 weeks
Change in fasting serum glucose level
Change from baseline serum glucose level (mg/dL) at 24 weeks
Time frame: 24 weeks
Change in quantity of food consumption
Change from baseline of calorie consumption (kcal) at 24 weeks
Time frame: 24 weeks
Plan to share: Yes — The investigators plan to share de-identified all IPD included in this study and that de-identified IPD results that underlie applications for additional funding or for publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Following publication. No end date.
Access criteria: To achieve aims in the approved proposal.
Ran from Sep 2020 to primary completion in Jun 2022, 21 months.
Of 16 phase 4 interventional studies under Vascular Diseases, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 84. This study's 21 months is below that.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dolutegravir