HIV-1-infection
Conditions
Keywords
Biktarvy, HIV-1 infection
Brief summary
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Detailed description
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
Interventions
DRUGB/F/TAF
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
DRUGTDF/3TC/EFV
TDF/3TC/EFV
Sponsors
Peking Union Medical College Hospital
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
Intervention model description
Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 \< 200/mm3, VL \>1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
Exclusion criteria
1. A new AIDS-defining condition diagnosed within the 30 days prior to screening 2. Participants experiencing severe organ lesion. 3. Positive serum pregnancy test or planned to be pregnant. 4. Females who are breastfeeding 5. With carcinoma 6. Concomitant medication of immunosuppression or chemoradiotherapy 7. Participation in any other interventional clinical trial 8. Screening stage find: Hb \< 9g/dL, WBC \< 3000/ul. neutrophilic granulocyte\< 1500/ul, PLT\< 75000/ul. Scr \> 1.5 ULN,Hepatic transaminases (AST and ALT) and ALP \> 3 × ULN,total bilirubin ≤ 2 x ULN. 9. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12 | Weeks 12 | Proportion of participants with HIV-1 RNA \< 50 copies/mL at Weeks 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 4,24,48 | Weeks 4,24,48 | Proportion of participants with HIV-1 RNA \< 50 copies/mL at Weeks 4,24,48 |
| The Change in CD4 T cell count from baseline at Weeks 12,24,48 | Weeks 12,24,48 | The Change in CD4 T cell count from baseline at Weeks 12,24,48 |
| Change in CD4/CD8 ratio from baseline at Weeks 12,24,48 | Weeks 12,24,48 | Change in CD4/CD8 ratio from baseline at Weeks 12,24,48 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Lyu
Department of Infectious Diseases, PekingUMCH
Outcome results
None listed