UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

United BioPharma

Status and phase: Not yet enrolling; Phase 3

Conditions: HIV-1 Infection

Treatments: Other: Antiretroviral (ARV); Biological: UB-421

Study type: Interventional

Funder types: Industry

Identifiers

NCT04406727

UBP-A308-HIV

Details and patient eligibility

About

The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV-1 seropositive
2. Have a history of at least 6 months on antiretroviral treatment
3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion criteria

1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
2. Females who are pregnant
3. Any vaccination within 2 weeks prior to the Screening
4. Any prior exposure to UB-421

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

UB-421

Experimental group

Description:

2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Treatment:

Other: Antiretroviral (ARV)

Biological: UB-421

Placebo

Active Comparator group

Description:

2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Treatment:

Other: Antiretroviral (ARV)