Vascular Diseases Clinical Trial
Official title:
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV
Verified date | July 2023 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 25, 2023 |
Est. primary completion date | June 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
Cottrell ML, Hadzic T, Kashuba AD. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clin Pharmacokinet. 2013 Nov;52(11):981-94. doi: 10.1007/s40262-013-0093-2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in cholesterol | Change from baseline cholesterol (mg/dL) at 24 weeks | 24 weeks | |
Other | Change in triglycerides | Change from baseline triglycerides (mg/dL) at 24 weeks | 24 weeks | |
Other | Change in high density lipoprotein (HDL) | Change from baseline HDL (mg/dL) at 24 weeks | 24 weeks | |
Other | Change in low density lipoprotein (LDL) | Change from baseline LDL (mg/dL) at 24 weeks | 24 weeks | |
Other | Change in HIV-1 RNA viral load | Change from baseline HIV-1 viral load (copies) at 24 weeks | 24 weeks | |
Other | Change in fasting serum glucose level | Change from baseline serum glucose level (mg/dL) at 24 weeks | 24 weeks | |
Other | Change in quantity of food consumption | Change from baseline of calorie consumption (kcal) at 24 weeks | 24 weeks | |
Primary | Change in Weight | Change from baseline kilograms (kg) of weight at 24 weeks | 24 weeks | |
Secondary | 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) | 24 weeks | |
Secondary | Change in vascular endothelial function | Change from baseline vessel diameter (millimeters) at 24 weeks | 24 weeks | |
Secondary | Height | Measurement of height (centimeters) from baseline to 24 weeks | 24 weeks |
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 |
NCT00000530 -
Raynaud's Treatment Study (RTS)
|
Phase 3 | |
Completed |
NCT00000539 -
Arterial Disease Multifactorial Intervention Trial (ADMIT)
|
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 |