Study to see the changes in body weight and body composition of a darunavir/cobicistat based treatment in HIV-infected people who have gained weight during a dolutegravir-based treatment.

Phase 1

• Conditions: HIV infection; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004620-38-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Adult = 18 years old having a diagnosis of HIV-1 infection.
2.Current ARV therapy with Triumeq® started at least 6 months before baseline.
3.Evidence of gain weight =5% during treatment with Triumeq® not associated with any medical condition or change of habit.
4.Maintained undetectable plasma HIV-1 RNA (viral load < 50 copies/mL) for at least 12 months before baseline.
5.Voluntary written informed consent.
6.In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
7.Commitment to follow the study procedures and avoid starting activities that may result in weight gain/decrease during the study.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Previous virological failure to protease inhibitors.
2.Suspected or documented resistance mutations to the protease, as well as NRTI–related mutations that may impact nucleoside activity.
3.Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, or any other condition that could impair subject’s safety, according to investigator criteria.
4.Treatment with drugs or other conditions that induce an increase (corticosteroids, antidepressants and antipsychotics, stop smoking habit, etc) or decrease (amphetamine, antidiabetics, diet, etc) of body fat.
5.Pregnant or breastfeeding women.

Study & Design

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