Clinical trial NCT06117657: Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
Official title: Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: HIV Infections
Lead sponsor: Affiliated Hospital of Guangdong Medical University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Low dose group will be administrated with 2.4×10\^11 vg/kg; Middle dose group will be administrated with 8.0×10\^11 vg/kg; High dose group will be administrated with 2.4×10\^12 vg/kg;
Primary purpose: TREATMENT

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 broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.

Eligibility 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.

Primary outcomes:
measure: Number and severity of AEs and SAEs
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: Neutralizing Antibodies Against KL-HIV-Tri01 Capsid
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: Inhibitors of broadly neutralizing antibodies
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: Cells mediated immune response against capsids and bNabs
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Secondary outcomes:
measure: Concentration and titer of serum neutralizing antibodies
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: CD4+T, CD8+T cell count
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: viral load
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
measure: Time to interrupt HAART treatment
timeFrame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Guangdong Medical University
name: Honghua He, MD
role: PRINCIPAL_INVESTIGATOR
References: