Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV (NCT05330143) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
China19 participantsStarted 2022-06-28
Plain-language 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 subjects living with human immunodeficiency virus type 1.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.