A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir
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|ClinicalTrials.gov Identifier: NCT04985890|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : August 2, 2021
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Biological: UB-421 Other: UB-421+chidamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 2022|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Experimental: UB-421 monotherapy
Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks.
UB-421 will be used 10mg/kg weekly intravenous infusion for 8 weeks. Antiretroviral therapy will be interrupted during entire study.
Experimental: UB-421 + chidamide combination therapy
Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks.
10 mg/kg UB-421 weekly intravenous infusion combined with oral 10 mg chidamide twice a week for 8 weeks. The dates of taking chidamide will be on the one day and three days after the first administration of UB-421.Antiretroviral therapy will be interrupted during entire study.
- HIV-1 Total DNA levels [ Time Frame: screening visit and week 9 ]The change in HIV-1 Total DNA from baseline at the ninth week after the first administration.
- HIV-1 Total DNA levels [ Time Frame: screening visit, week 4,9 and 14 ]The changes in HIV-1 Total DNA levels during the study
- Treatment related TEAE [ Time Frame: through study completion, an average of 0.5 year ]The incidence of Grade 3 or higher grade drug-related treatment-emergent adverse events (TEAE)
- Viral suppression [ Time Frame: screening visit and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 14 ]Descriptive analysis of loss of viral suppression (HIV-1 VL> 50 copies/ml) during the study period.
- Tolerability of study treatment [ Time Frame: week 1 to week 8 ]The number of adverse events leading to discontinuation of UB 421 or Chidamide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985890
|Contact: Linda Shih, MSc||+886 36684800 ext email@example.com|
|Study Chair:||undergoing undergoing, MD||undergoing|