Safety, tolerability, and efficacy of a dose reduction strategy based on bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-infected adults.
- Conditions
- HIV infectionMedDRA version: 20.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2022-000358-26-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
1) Stable and asymptomatic HIV-infected adults (=18 years) on BETAF once daily for at least the previous 6 months.
2) Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months
3) CD4 cell counts greater than 350 cells/mL at the time of consideration for the study
4) Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods
5) Patients agreed to participate
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1) Prior virological failure to any antiretroviral regimen or documented resistance mutations to bictegravir, emtricitabine, or tenofovir
2) Any diagnosis of psychiatric illness
3) Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment)
4) Patients co-infected with HIV and active hepatitis B or C virus
5) Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method