Trials / Unknown
UnknownNCT03164447
UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients
A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination With Optimized Background Therapy (OBT) Regimen in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- United BioPharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-421 | Monoclonal antibody by IV infusion |
| DRUG | Optimized background therapy (OBT) | The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-03-01
- Completion
- 2024-05-01
- First posted
- 2017-05-23
- Last updated
- 2023-04-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03164447. Inclusion in this directory is not an endorsement.