Status:
COMPLETED
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Conditions:
HIV-1-infection
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subject...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤ 60 years old at screening.
- Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
- Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
- CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
- Weight ≥ 50 kg at screening.
Exclusion
- Known allergy to the drug or excipients used in this trial.
- HIV-associated opportunistic infections in the past 5 years.
- Co-sensors of HBV, HCV, syphilis, etc.
- With bleeding disorders or on anticoagulant therapy.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05330143
Start Date
June 28 2022
End Date
May 15 2024
Last Update
November 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Fifth Medical Center of the General Hospital of the Peoples Liberation Army
Beijing, Beijing Municipality, China, 100071