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

United BioPharma

Status and phase: Not yet enrolling; Phase 2

Conditions: HIV-1-infection

Treatments: Biological: UB-421(25 mg/kg) Q2W; Biological: UB-421(25 mg/kg) Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT04404049

UBP-A218-HIV

Details and patient eligibility

About

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-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.

Enrollment: 39 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Standard ART

No Intervention group

Description:

Subjects will receive standard ART for 48 weeks

UB-421(25mg/kg) Q2W add-on treatment

Experimental group

Description:

UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks

Treatment:

Biological: UB-421(25 mg/kg) Q2W

UB-421(25mg/kg) Q4W add-on treatment

Experimental group

Description:

UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks

Treatment:

Biological: UB-421(25 mg/kg) Q4W