NCT05330143CompletedPhase 2
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
A Phase II Multi-center, Randomized, Blind, Placebo-controlled Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus
Source: ClinicalTrials.gov · Last updated 25 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 17 Mar 2022
- Start date
- 28 Jun 2022
- Primary completion date
- 15 May 2024
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Diseases
- HIV
- NCT number
- NCT05330143
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 19
- From 28 Jun 2022 to the primary completion date, 15 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fifth Medical Center of the General Hospital of the Peoples Liberation Army Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.