Status:
UNKNOWN
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
Lead Sponsor:
UBP Greater China (Shanghai) Co., Ltd
Conditions:
HIV-1-infection
Eligibility:
All Genders
20-100 years
Phase:
PHASE2
Brief Summary
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treate...
Eligibility Criteria
Inclusion
- HIV-1 sero-positive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- HIV-1 plasma RNA level below 50 RNA copies/mL.
Exclusion
- Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
- Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- History of anaphylaxis to other mAbs.
- Any vaccination within 8 weeks prior to the first dose of assigned drug.
- Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04404049
Start Date
December 1 2023
End Date
June 30 2025
Last Update
May 18 2022
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