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

Affiliated Hospital of Guangdong Medical University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

HIV Infections

Treatments

Drug: Middle dose KL-HIV-Tri01

Drug: High dose KL-HIV-Tri01

Drug: Low dose KL-HIV-Tri01

Study type

Interventional

Funder types

Other

Identifiers

NCT06117657

CP-Tri01-001/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.

Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
CD4+T cell count≥500 cells/μl.
On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
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

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.