EUCTR2019-004999-19-DK
Active, not recruiting
Phase 1
Changes in weight, body composition and metabolic parameters after switch to dolutegravir/lamuvidine compared to continued treatment with dolutegravir/abacavir/lamuvidine for virologically suppressed HIV infection: A randomized open-label superiority trial. The AVERTAS-1 trial - AVERTAS-1
Department of infectious diseases, Hvidovre Hospital0 sites95 target enrollmentFebruary 14, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of infectious diseases, Hvidovre Hospital
- Enrollment
- 95
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Individuals \= 18 years old with
- •\- Diagnosed HIV and
- •\- At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine prior to inclusion
- •\- No pre\-existing viral resistance mutations to lamivudine or to dolutegravir
- •\- Plasma viral load (HIV\-RNA) \< 50 copies/ml
- •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 80
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Pre\-existing viral resistance mutations to lamivudine or to dolutegravir
- •\- Presence of hepatitis B antigen (HBsAg) or HBV DNA
- •\- Cancer within past 5 years
- •\- Pregnancy or breastfeeding
- •\- Any case of diabetes or cardiovascular disease must be stable as assessed by the treating physician
- •\- Women of reproductive potential will be included if using approved contraception
Outcomes
Primary Outcomes
Not specified
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