Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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: 1. whether dolutegravir based regimen increases body weight 2. the mechanisms whereby dolutegravir increases body weight 3. whether dolutegravir-mediated body weight gain increases the risk for CVD in PLWH. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04340388
Study type Interventional
Source Augusta University
Contact
Status Completed
Phase Phase 4
Start date September 17, 2020
Completion date February 25, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05971407 - The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Recruiting NCT04390672 - Multivessel TALENT N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Completed NCT01684826 - X-ray Dose Reduction Study for Cardiac Angiography and Intervention N/A
Completed NCT01417910 - Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients N/A
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Unknown status NCT01748383 - The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction) Phase 2
Recruiting NCT05907564 - Aventus Thrombectomy System Pulmonary Embolism Clinical Study N/A
Recruiting NCT03732612 - Inflammation in Vascular Disease
Completed NCT00000614 - Prevention of Recurrent Venous Thromboembolism (PREVENT) Phase 3
Completed NCT00000539 - Arterial Disease Multifactorial Intervention Trial (ADMIT) Phase 3
Completed NCT00000530 - Raynaud's Treatment Study (RTS) Phase 3
Completed NCT00000479 - Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer Phase 3
Completed NCT00000474 - Prevention and Treatment of Hypertension Study (PATHS) Phase 3
Completed NCT00000528 - Trials of Hypertension Prevention (TOHP) Phase 3
Completed NCT00000509 - Potassium and Sodium to Control Blood Pressure in Hypertensives Phase 3
Completed NCT00000501 - Hypertension Prevention Trial (HPT) Feasibility Study Phase 2
Completed NCT00000499 - Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study) Phase 2