Clinical trial NCT05122754: Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection
Official title: Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: Bictegravir/Emtricitabine/Tenofovir alafenamide
Tenofovir Disoproxil Fumarate
HIV-1 infection
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
Collaborators: name: Xixi Hospital of Hangzhou
name: Yunnan AIDS Care Center
First posted: 2021-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus tenofovir disoproxil fumarate-based antiretroviral regimens in HIV-infected individuals with virological suppression.

Detailed description: This study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of B/F/TAF versus TDF-based antiretroviral therapy in HIV-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a TDF-based regimen to B/F/TAF in HIV-infected individuals with virological suppression.

Eligibility criteria: Inclusion Criteria:

* Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
* Age 18 or above (included 18);
* Continuous administration of a TDF-based triple ART regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use;
* Maintaining virological suppression (viral load \< 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
* Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);
* ECG is normal;
* White blood cell count ≥3×109/L, Neutrophil count ≥1.5×109/L, Hemoglobin ≥90 g/L, and Platelet count ≥ 75×109/L;
* Alanine aminotransferase and aspartate aminotransferase ≤5×ULN, direct bilirubin ≤1.5×ULN, amylase≤2×ULN；
* Those who volunteered for this study and were able to complete all follow-up visits and sign the informed consent form in accordance with the protocol.

Exclusion Criteria:

* In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
* History of known past HIV resistance (confirmed HIV viral load \> 200 copies /ml) or resistance to any nucleoside (acid) analogues;
* Decompensated liver cirrhosis;
* Female subject who has a positive urine pregnancy test;
* Lactating women;
* Women who are unable to take a reasonable method of contraception during the trial (including the Screening Period and 30 days after discontinuation of experimental drugs);
* Subjects had other medical conditions requiring treatment with either of the current ART regimens or other drugs which have drug-drug interaction with B/F/TAF and cannot be discontinued.
* Being involved in other interventional clinical studies;
* Those with allergic constitution or known allergy to the components of the drug;
* Suffering from serious mental or neurological diseases;
* Suspected or confirmed history of alcohol and drug abuse; Patients who were not considered by the investigator to be suitable for participating in this clinical trial (such as weak constitution, poor compliance, etc.).

Primary outcomes:
measure: Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
timeFrame: From baseline to Week 48
Secondary outcomes:
measure: Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24
timeFrame: From baseline to Week 24
measure: The percentage of subjects with spine or hip bone mineral density (DXA) that increased or decreased by more than 3% (not included) from baseline at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)
timeFrame: From baseline to Week 24, 48
measure: The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Changes from baseline in CD4 T cell count at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48
timeFrame: From baseline to Week 24, 48
measure: Patients reported outcome using SSC-HIV-SC scale
timeFrame: From baseline to Week 24, 48
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Kunming
country: China
facility: Yunnan AIDS Care Center
state: Yunnan
city: Hangzhou
country: China
facility: Xixi hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Jun Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References: