The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
NCT ID: NCT04404049
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
39 participants
INTERVENTIONAL
2023-12-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard ART
Subjects will receive standard ART for 48 weeks
No interventions assigned to this group
UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
UB-421(25mg/kg) Q4W add-on treatment
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART
Interventions
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UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART
Eligibility Criteria
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Inclusion Criteria
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. HIV-1 plasma RNA level below 50 RNA copies/mL.
Exclusion Criteria
2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
4. History of anaphylaxis to other mAbs.
5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
20 Years
100 Years
ALL
No
Sponsors
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UBP Greater China (Shanghai) Co., Ltd
INDUSTRY
Responsible Party
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Other Identifiers
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UBP-A218-HIV
Identifier Type: -
Identifier Source: org_study_id
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