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

NCT06117657 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-11-08

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • Affiliated Hospital of Guangdong Medical University

    lead OTHER

Principal Investigators

  • Honghua He, MD · Affiliated Hospital of Guangdong Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-08-20
Completion
2025-09-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117657 on ClinicalTrials.gov