NCT03743376CompletedPhase 2
The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
United BioPharma4 sites in 1 country31 target enrollmentStarted: December 12, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- treatment related TEAEs
Study Overview
Brief Summary
This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-
- •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.
Outcomes
Primary Outcomes
treatment related TEAEs
Time Frame: 48Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
Secondary Outcomes
- the change of immune profiles(16Weeks)
Investigators
Study Sites (4)
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