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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
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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
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Central trial contact
Honghua He, MD
Data sourced from clinicaltrials.gov
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