Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT05582694
Status:
WITHDRAWN
Last Update Posted:
2025-07-11
First Post:
2022-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with recruitment and drug production.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Study Description:
This is a Phase 2 single arm study to evaluate the efficacy and safety of UB-421 in conjunction with an existing failing antiretroviral therapy (ART) for 2 weeks followed by optimized background therapy (OBT) in conjunction with UB-421 for 24 weeks.
Objectives:
Primary Objectives:
To assess the antiviral activity of UB-421 in reducing human immunodeficiency virus type 1 (HIV-1) plasma viremia during the 2-week functional monotherapy treatment period.
Secondary Objectives:
* Evaluate the antiviral activity of UB-421 during the 24-week maintenance treatment period.
* Evaluate changes from baseline in CD4+ and CD8+ T cell counts during the UB-421 treatment period.
* Evaluate the pharmacokinetic parameters of UB-421.
* Evaluate the immunogenicity of UB-421 by the presence of anti-UB-421 antibodies.
Endpoints:
Primary Efficacy Endpoint:
-Number of participants with \>=0.5 log10 reduction in HIV-1 plasma viremia from baseline (Day 7) to Day 21.
Primary Safety Endpoint:
-The number of grade 2 or higher adverse events (AEs), including serious adverse events (SAEs), which are possibly, probably or definitely related to UB-421.
Secondary Endpoints:
* Number of participants achieving \>=1 log10 reduction in HIV-1 plasma viremia from baseline (Day 7) to Day 21.
* Number of participants achieving HIV-1 plasma viremia \<40 copies/mL at the end of treatment (EOT-Study week 27).
* Number of participants achieving HIV-1 ribonucleic acid (RNA) \<200 copies/mL at the EOT.
* Mean change in CD4+ and CD8+ T cell counts from baseline (Day 7) to EOT for all evaluable subjects.
* Measured levels of anti-UB-421 antibodies in participant blood samples.
* Measured levels of serum UB-421 concentration (pharmacokinetic parameters) in participant blood samples.
This is a Phase 2 single arm study to evaluate the efficacy and safety of UB-421 in conjunction with an existing failing antiretroviral therapy (ART) for 2 weeks followed by optimized background therapy (OBT) in conjunction with UB-421 for 24 weeks.
Objectives:
Primary Objectives:
To assess the antiviral activity of UB-421 in reducing human immunodeficiency virus type 1 (HIV-1) plasma viremia during the 2-week functional monotherapy treatment period.
Secondary Objectives:
* Evaluate the antiviral activity of UB-421 during the 24-week maintenance treatment period.
* Evaluate changes from baseline in CD4+ and CD8+ T cell counts during the UB-421 treatment period.
* Evaluate the pharmacokinetic parameters of UB-421.
* Evaluate the immunogenicity of UB-421 by the presence of anti-UB-421 antibodies.
Endpoints:
Primary Efficacy Endpoint:
-Number of participants with \>=0.5 log10 reduction in HIV-1 plasma viremia from baseline (Day 7) to Day 21.
Primary Safety Endpoint:
-The number of grade 2 or higher adverse events (AEs), including serious adverse events (SAEs), which are possibly, probably or definitely related to UB-421.
Secondary Endpoints:
* Number of participants achieving \>=1 log10 reduction in HIV-1 plasma viremia from baseline (Day 7) to Day 21.
* Number of participants achieving HIV-1 plasma viremia \<40 copies/mL at the end of treatment (EOT-Study week 27).
* Number of participants achieving HIV-1 ribonucleic acid (RNA) \<200 copies/mL at the EOT.
* Mean change in CD4+ and CD8+ T cell counts from baseline (Day 7) to EOT for all evaluable subjects.
* Measured levels of anti-UB-421 antibodies in participant blood samples.
* Measured levels of serum UB-421 concentration (pharmacokinetic parameters) in participant blood samples.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 22-I-0008 | None | None | View |