EUCTR2020-000205-89-DKActive, not recruitingPhase 1
Changes in weight, body composition and metabolic parameters after switch to either dolutegravir/lamivudine or doravirine/tenofovir/lamivudine compared to continued treatment with dolutegravir/tenofovir/lamivudine for virologically suppressed HIV infection: A randomized open-label superiority trial. The AVERTAS-2 trial.
Department of Infectious Diseases, Hvidovre Hospital0 sites126 target enrollmentStarted: February 14, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Individuals >18 years
- •- Diagnosed HIV
- •- At least 6 months of ongoing treatment with dolutegravir/ tenofovirdisproxil/lamivudin prior to inclusion
- •- Plasma viral load (HIV-RNA) < 50 copies/ml
- •- Women of reproductive potential will be included if using approved contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine
- •- History of or positive hepatitis B antigen (HBsAg) test
- •- Cancer within the 5 past years
- •- Pregnancy or breastfeeding
- •- Any case of diabetes or cardiovascular disease must be stable assessed by the treating physician
Investigators
Similar Trials
Active, not recruiting
Phase 1
Changes in weight, body composition and metabolic parameters in HIV infected patients after switched treatmentEUCTR2019-004999-19-DKDepartment of infectious diseases, Hvidovre Hospital95
Not yet recruiting
Not Applicable
Changes in body composition, dietary intake, and physical activity in children with cancer - a master protocolGewichtsstoornissenbody compositionNutritional status1000301810027655NL-OMON56855Prinses Máxima Centrum voor Kinderoncologie500
Completed
Not Applicable
Body compositional and endocrine-metabolic changes by long-term lifestyle intervention with health education, diet (Almased®), physical activity or a combination of diet and physical activity in obese personsDietoverweightE66.0Obesity due to excess caloriesDRKS00000010niversitätsklinikum Freiburg114
Completed
Not Applicable
Changes in body (size, blood etc.) due to intake of test articleHealthy adultJPRN-UMIN000036840Japan Clinical Trial Association72
Not yet recruiting
Unknown
Short-term weight loss and body composition changes in patients with obesity by GLP-1 and GIP/GLP-1 receptor agonists in combination with low-calorie diet.obesityJPRN-UMIN000053234Kimitsu Chuo Hospital40