The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard ART

Subjects will receive standard ART for 48 weeks

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

UB-421(25 mg/kg) Q2W

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

UB-421(25 mg/kg) Q4W

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

UB-421(25 mg/kg) Q4W

Monoclonal antibody by IV infusion plus standard ART

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. HIV-1 sero-positive
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

1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No