Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects

• Status: Not yet recruiting
• Trial end date: 2025-09-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Guangdong Medical University

Criteria

Inclusion Criteria:

1.18 (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 Criteria:

1. 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.

2. Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.

3. Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.

4. Currently treated with Immunosuppressive medications or steroids.

5. Previous receipt of HIV vaccine, antibody or gene therapy.