Changes in weight, body composition and metabolic parameters in HIV infected patients after switch from 2- to 3-drug treatment

Phase 1

• Conditions: Human immunodeficiency virus (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: EUCTR2020-000205-89-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: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 126

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

Study & Design

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