NCT05602506CompletedPhase 4
Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 19 Oct 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Diseases
- HIV
- NCT number
- NCT05602506
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- From 15 Nov 2022 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior virological failure to any antiretroviral regimen or documented.
- Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).
Other illness
- Any diagnosis of psychiatric illness.
- Patients co-infected with HIV and active hepatitis B or C virus.
- Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.
Who the study is looking for
- Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.
- Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.
- CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.
- 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.
- Patients agreed to participate.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic i Provincial Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.