Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: B/F/TAF group Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks. |
Drug: B/F/TAF
Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
|
| Active Comparator: TDF-based triple ART regimen switching to B/F/TAF TDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks. |
Drug: TDF-based triple ART regimen switching to B/F/TAF
Tenofovir disoproxil fumarate was administered once daily, one tablet at a time, with or without food. After Week 24, control subjects were also switched to bictegravir/emtricitabine/tenofovir alafenamide once daily, one tablet at a time, with or without food for the later 24 weeks.
|
Outcome Measures
Primary Outcome Measures
- Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks [From baseline to Week 48]
Secondary Outcome Measures
- Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24 [From baseline to Week 24]
- 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 [From baseline to Week 24, 48]
- Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48 [From baseline to Week 24, 48]
- Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula) [From baseline to Week 24, 48]
- The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48 [From baseline to Week 24, 48]
- Changes from baseline in CD4 T cell count at Weeks 24 and 48 [From baseline to Week 24, 48]
- Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48 [From baseline to Week 24, 48]
- Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48 [From baseline to Week 24, 48]
- Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48 [From baseline to Week 24, 48]
- Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48 [From baseline to Week 24, 48]
- Patients reported outcome using SSC-HIV-SC scale [From baseline to Week 24, 48]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
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Age 18 or above (included 18);
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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;
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Maintaining virological suppression (viral load < 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
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Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);
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ECG is normal;
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White blood cell count ≥3×109/L, Neutrophil count ≥1.5×109/L, Hemoglobin ≥90 g/L, and Platelet count ≥ 75×109/L;
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Alanine aminotransferase and aspartate aminotransferase ≤5×ULN, direct bilirubin ≤1.5×ULN, amylase≤2×ULN；
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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:
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In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
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History of known past HIV resistance (confirmed HIV viral load > 200 copies /ml) or resistance to any nucleoside (acid) analogues;
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Decompensated liver cirrhosis;
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Female subject who has a positive urine pregnancy test;
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Lactating women;
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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);
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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.
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Being involved in other interventional clinical studies;
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Those with allergic constitution or known allergy to the components of the drug;
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Suffering from serious mental or neurological diseases;
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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.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Public Health Clinical Center | Shanghai | Shanghai | China | 201508 |
| 2 | Yunnan AIDS Care Center | Kunming | Yunnan | China | |
| 3 | Xixi hospital of Hangzhou | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Shanghai Public Health Clinical Center
- Xixi Hospital of Hangzhou
- Yunnan AIDS Care Center
Investigators
- Principal Investigator: Jun Chen, M.D, Shanghai Public Health Clinical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B/F/TAF