Trials / Not Yet Recruiting
Not Yet RecruitingNCT04985890
A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir
A Proof of Concept Study to Evaluate the Safety and Efficacy of UB-421 in Combination With Chidamide for Reduction of HIV Reservoir as Compared to UB-421 Alone in ART Stabilized HIV-1 Patients Who Undergo ART Interruption
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
* To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption. * To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-421 | 10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy |
| OTHER | UB-421+chidamide | 10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks. Chidamide taken on the one day and three days after the administration of UB-421. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2021-08-02
- Last updated
- 2023-05-10
Source: ClinicalTrials.gov record NCT04985890. Inclusion in this directory is not an endorsement.