HIV
Conditions
Interventions
Treatment-na?ve people living with HIV (antiretroviral therapy on BIC/FTC/TAF):None
treatment-experienced people living with HIV (switch from other regimens to BIC/FTC/TAF for antiretroviral therapy:None
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria (Common to both cohorts) (1) Adult individuals (>18 years) with documented HIV-1 infection; (2) presence of one or more major INSTI-resistance mutations (such as T66A/I/K, E92Q, N155H, E138K/A/T, G140S/A/C/R) associated with reduced susceptibility to first-generation INSTIs on a baseline genotypic resistance test; (3) no BIC resistance. 2. Cohort A Specific Inclusion Criteria ART-naive (defined as <=14 days of prior ART exposure). 3. Cohort B Specific Inclusion Criteria Treatment-experienced and on a stable antiretroviral regimen (no BIC/FTC/TAF) at least 6 months prior to study entry;HIV-1 RNA < 50 copies/mL prior to study initiation.
Exclusion criteria
Exclusion criteria: 1. Co-administration of other antiretroviral drugs; 2. active, untreated opportunistic infection that could interfere with the study; 3. severe hepatic impairment (Child-Pugh Class C); 4. any contraindication to any component of the BIC/FTC/TAF regimen; 5. individuals planning pregnancy during follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV RNA load; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug resistance test;index for liver and kidney function;complete blood count;CD4 cell counts; | — |
Countries
China
Contacts
Public ContactHongxin Zhao
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed