Changes in weight, body composition and metabolic parameters in HIV infected patients after switched treatment

Phase 1

• Conditions: Human immunodeficiency viruses (HIV); MedDRA version: 21.1Level: PTClassification code 10067326Term: Antiretroviral therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-004999-19-DK
• Lead Sponsor: Department of infectious diseases, Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-14
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

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
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified