Clinical trial NCT04296695: Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Official title: The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: Biktarvy
HIV-1 infection
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-03-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with HIV-1 RNA
timeFrame: base line,Weeks 12,24 and 48
measure: The Change in CD4 T cell count from baseline
timeFrame: base line,Weeks 12, 24 and 48
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: The Guangxi Zhuang Autonomous Region Longtan Hospital
state: Guangxi
city: Najing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
Study officials:
affiliation: Department of Infectious Diseases, PekingUMCH
name: Wei Lyu
role: PRINCIPAL_INVESTIGATOR
References: