Not Yet RecruitingPhase 3

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

50 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Change in HIV-1 RNA viral load between 2 arms

Timeframe: 14 Days

Trial details

NCT IDNCT04406727

SponsorUnited BioPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Linda Shih

+886-3-668-4800 linda.shih@unitedbiopharma.com

View on ClinicalTrials.gov More HIV-1 Infection trials