Status:
UNKNOWN
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 h...
Eligibility Criteria
Inclusion
- 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
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Participants experiencing severe organ lesion.
- Positive serum pregnancy test or planned to be pregnant.
- Females who are breastfeeding
- With carcinoma
- Concomitant medication of immunosuppression or chemoradiotherapy
- Participation in any other interventional clinical trial
- 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.
- 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
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04296695
Start Date
July 14 2021
End Date
December 31 2023
Last Update
February 8 2023
Active Locations (3)
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1
The Guangxi Zhuang Autonomous Region Longtan Hospital
Liuchow, Guangxi, China, 545005
2
The Second Hospital of Nanjing
Najing, Jiangsu, China, 210003
3
Tianjin Second People's Hospital
Tianjin, China, 300192