WITHDRAWN

A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection

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Conditions

Multi-Drug Resistant Hiv-1 InfectionHIV-1 InfectionHIV TherapyCd4-Specific Humanized Igg1 Monoclonal Antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated. Untreated HIV infection can make people more vulnerable to other infections as well as some cancers. Better treatments are needed for people with drug-resistant HIV. Objective: To see if a study drug (UB-421) is effective in people with drug-resistant HIV. Eligibility: People aged 18 years and older with HIV that is resistant to anti-HIV drugs. Design: Participants will be in the study for 35 weeks. Participants will have separate screening and baseline visits within 2 months of each other. They will have a physical exam with blood and urine tests both times. On the second visit, they will undergo apheresis: Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. Participants will begin receiving the study drug 1 week after their baseline visit. UB-421 is given through a tube attached to a needle placed in a vein in the arm. They will return for UB-421 treatments every week for 26 weeks. Each visit will take 3 to 6 hours. Participants will have 2 follow-up visits 4 and 8 weeks after their last treatment with UB-421. Apheresis will be repeated at 1 of these visits.

Official Title

A Single Arm Open Label Phase 2 Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection

Quick Facts

Study Start:2025-07-10
Study Completion:2025-07-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05582694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent;
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study;
  3. * Aged 18 years or older;
  4. * Have a life expectancy that is \>6 months (as judged by the Principal Investigator \[PI\]);
  5. * HIV-1 seropositive;
  6. * Have a history of being treated for at least 6 months with ART;
  7. * Plasma HIV-1 RNA \>= 1,000 copies/mL at the Screening visit;
  8. * Screening CD4+ T cell counts of \> 350 cells/mm3;
  9. * Documented genotypic or phenotypic resistance to at least one ARV drug within three or more drug classes of ARV medications;
  10. * Receiving a stable failing regimen of cART for at least 8 weeks before Screening and are willing to continue the failing regimen during the Screening Phase and up to study day 21 of the Treatment Phase, OR have failed a regimen within 8 weeks of Screening, are off ART and are willing to stay off ART until day 21 of the Treatment Phase. Patients who failed to attain or maintain complete suppression of plasma viremia while receiving fostemsavir will not be allowed to enroll in the study. Patients who failed to attain or maintain complete suppression of plasma viremia while receiving ibalizumab-based salvage regimen will be allowed to enroll in this study; however, prior ibalizumab use must have ended at least five half-lives (i.e., 21 days) before the first dose of UB-421;
  11. * Have viral sensitivity to at least one FDA-approved ARV agent, as determined by genotypic or phenotypic ARV drug resistance testing, and such agent can be used as a component of OBT. Patients currently receiving enfuvirtide, ibalizumab, or maraviroc will be excluded from this study, unless patients agree to discontinue these drugs for at least five half-lives (i.e., 1 day, 21 days or 4 days, respectively), before the first dose of UB-421. These drugs also will not be allowed as a component of OBT;
  12. * 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;
  13. * For females of reproductive potential: use of highly effective contraception - as detailed in the Centers for Disease Control and Prevention (CDC) US Selected Practice Recommendations for Contraceptive Use (US SPR) - for at least 1 month prior to Baseline visit and agreement to use such a method during study participation and for an additional 4 weeks after the end of UB-421 administration. For males of reproductive potential, for at least 1 month prior to Baseline visit and agreement to use such a method during study participation and for an additional 4 weeks after the end of UB-421 administration: use of condoms or other methods to ensure effective contraception with partner of childbearing potential; Non-reproductive potential is defined as azoospermia, postmenopausal, surgical sterilization at least 6 weeks before screening, or a congenital or acquired condition that definitively prevents conception. Further, postmenopausal is defined as at least 12 consecutive months with no menses at age 50 or older, and also a high follicle-stimulating hormone level in postmenopausal range at ages 45-50 years, for participants not using hormonal contraception or hormone replacement therapy.
  14. * Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide).
  15. * Cervical cap with spermicide (only for nulliparous partners).
  16. * Contraceptive sponge (only for nulliparous partners).
  17. * Male or female condom (cannot be used together).
  18. * Intrauterine device.
  19. * Hormonal contraception: pill (estrogen/progestin or progestin-only), skin patch, vaginal ring, rod implanted in the skin, or subcutaneous injection.
  20. * Absolute neutrophil count (ANC) \>= 750/mm3;
  21. * Hemoglobin (Hb) \>= 10.5 gm/dL (male) or \>= 9.5 gm/dL (female);
  22. * Platelets \>= 50,000 /mm3;
  23. * Serum alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN);
  24. * Serum AST \< 2.5 x ULN;
  25. * Bilirubin (total) \< 2.5 x ULN (Exceptions: Gilbert's disease, or the subject is receiving atazanavir and there is no evidence of significant liver disease);
  26. * Estimated or a measured glomerular filtration rate \>60 mL/min/1.73 m2 as determined by the NIH CC laboratory.
  1. * Chronic hepatitis B, as evidenced by a positive test for HBsAg, or chronic hepatitis C virus (HCV) infection, as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
  2. * AIDS-defining Stage 3 opportunistic illnesses according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection \[11\] at or within 3 months of screening patients on maintenance therapy (for instance, for toxoplasmosis or
  3. * HIV immunotherapy (including broadly neutralizing HIV antibodies) within 12 weeks prior to screening;
  4. * Participation in an experimental drug trial(s) within 4 weeks prior to the Screening visit;
  5. * Pregnancy or lactation;
  6. * Any licensed or experimental vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (day 0);
  7. * Prior use of UB-421;
  8. * Any acute febrile illness within 14 days before initial administration of UB-421;
  9. * Treatment with another investigational drug or other intervention within 28 days of Screening;
  10. * Any active malignancy that may require systemic chemotherapy or radiation therapy;
  11. * History or other clinical evidence of:
  12. * Significant or unstable cardiac or cerebrovascular disease (e.g., angina, congestive heart failure, recent stroke or myocardial infarction);
  13. * Severe illness, malignancy, immunodeficiency other than HIV, or any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study;
  14. * Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements;
  15. * Systemic immunosuppressive medications received within 3 months prior to enrollment (Exceptions: \[1\] corticosteroid nasal spray or inhaler; \[2\] topical corticosteroids for mild, uncomplicated dermatitis; or \[3\] oral/parenteral corticosteroids administered for nonchronic

Contacts and Locations

Principal Investigator

Michael C Sneller, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Michael C Sneller, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10
Study Completion Date2025-07-10

Study Record Updates

Study Start Date2025-07-10
Study Completion Date2025-07-10

Terms related to this study

Keywords Provided by Researchers

  • HIV Therapy
  • Cd4-Specific Humanized Igg1 Monoclonal Antibody

Additional Relevant MeSH Terms

  • Multi-Drug Resistant Hiv-1 Infection
  • HIV-1 Infection