FindTrial
Sign In

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04406727
Enrollment
50
Registered
2020-05-28
Start date
2023-12-01
Completion date
2026-06-30
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Brief summary

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.

Interventions

BIOLOGICALUB-421

UB-421 in combination with their ARV

OTHERAntiretroviral (ARV)

Antiretroviral (ARV)

Sponsors

United BioPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in HIV-1 RNA viral load between 2 arms14 Days

Contacts

Primary ContactLinda Shih
linda.shih@unitedbiopharma.com+886-3-668-4800
Backup ContactZhonghao Shi
zhonghao.shi@unitedbiopharma.com+886-3-668-4800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026