Status:
UNKNOWN
Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
Lead Sponsor:
Affiliated Hospital of Guangdong Medical University
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.
Detailed Description
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broa...
Eligibility Criteria
Inclusion
- 18 (not inclusive) to 80 (inclusive) years of age, both male and female.
- 2\. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
- 3\. CD4+T cell count≥500 cells/μl.
- 4\. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
- 5\. Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.
Exclusion
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
- Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
- Currently treated with Immunosuppressive medications or steroids.
- Previous receipt of HIV vaccine, antibody or gene therapy.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06117657
Start Date
November 10 2023
End Date
September 10 2025
Last Update
November 8 2023
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