NCT06117657

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Affiliated Hospital of Guangdong Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Low dose KL-HIV-Tri01	Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10\^11 vg/kg.
DRUG	Middle dose KL-HIV-Tri01	Subjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10\^11 vg/kg.
DRUG	High dose KL-HIV-Tri01	Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10\^12 vg/kg.

Timeline

• Start date: 2023-11-10
• Primary completion: 2024-08-20
• Completion: 2025-09-10
• First posted: 2023-11-07
• Last updated: 2023-11-08