A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
NCT ID: NCT05056974
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2021-12-02
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UB-421 + chidamide
UB-421 + chidamide combination therapy
UB-421
10 mg/kg, weekly UB-421 during the 8-week
chidamide
10 mg/dose, twice a week for 8 weeks
Interventions
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UB-421
10 mg/kg, weekly UB-421 during the 8-week
chidamide
10 mg/dose, twice a week for 8 weeks
Eligibility Criteria
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Inclusion Criteria
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. No breastfeeding or pregnancy for women.
4. Have been receiving ART for more than 3 years by screening visit 1 (SV1).
5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
6. Subjects must sign the informed consent before undergoing any study procedures.
Exclusion Criteria
2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
4. Any alcohol or illicit drug use
5. Receipt of any other investigational study agent(s) within 90 days before SV2.
6. Currently on the treatment for diabetes.
20 Years
ALL
No
Sponsors
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United BioPharma
INDUSTRY
Responsible Party
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Locations
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, , Taiwan
Countries
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Other Identifiers
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UBP-A232-HIV
Identifier Type: -
Identifier Source: org_study_id
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