UnknownPhase 2

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients

10 participantsStarted 2023-12

Plain-language summary

This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks, respectively.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males and females, age ≥18 years;
✓. HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (eg. Laboratory report);
✓. Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening and are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
✓. Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA \>200 copies/ml) within the last 3 months prior to the Screening Visit;
✓. Highly treatment-experienced HIV-infected patients with documented genotypic and/or phenotypic resistance to at least one ARV drug within three or more drug classes of antiretroviral medications and have difficulty in constructing a viable suppressive regimen.
✓. Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than UB-421, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBT;
✓. Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure;
✓. Have a life expectancy that is \> 9 months;

Exclusion criteria

✕. Any currently active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: local cutaneous Kaposi's sarcoma, wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications;
✕. Subjects with baseline liver disease including active Hepatitis B or C infection or any other active infection secondary to HIV requiring acute therapy;
✕. Subjects with baseline CD4 counts \< 350 cells/mm\^3.
✕. Any ≥ Grade 3 laboratory abnormality according to the division of AIDS grading scale;
✕. Unexplained fever or clinically significant illness within 2 weeks prior to the first dose of study drug;
✕. Any vaccination within 2 weeks prior to the first dose of study drug;
✕. Any immunomodulating therapy (excluding pre-medication steroid) or systemic chemotherapy within 4 weeks prior to the Screening Visit;
✕. Any radiation therapy within 4 weeks prior to the Screening Visit;

What they're measuring

Effectiveness by Viral Load Log10 Change from Baseline

Timeframe: 2 weeks

Trial details

NCT IDNCT03164447

SponsorUnited BioPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03

Contact for this trial

Zhonghao Shi

+886-3-668-4800 Zhonghao.Shi@unitedbiopharma.com

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