To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults
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ClinicalTrials.gov Identifier: NCT02369146 |
Recruitment Status :
Completed
First Posted : February 23, 2015
Last Update Posted : October 31, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV-1 Infection | Drug: UB-421 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
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Drug: UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Other Name: dB4C7 mAb |
Experimental: cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
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Drug: UB-421
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
Other Name: dB4C7 mAb |
- Number of participants with adverse events [ Time Frame: 17 weeks for cohort 1, 25 weeks for cohort 2 ]
- Peak concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]
- Trough concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 sero-positive
- Aged 20 years or older
- Have received HAART treatment
- CD4+ T cell count ≧ 350 cells/mm3
- HIV-1 plasma RNA level remains below the limit of
- Were not breastfeeding for women
- Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
- Subjects agree on using birth control barrier (female or male condom) during the entire study period
- Subjects sign the informed consent before undergoing any study procedures
Exclusion Criteria:
- Any active infection except for HIV, and required immediate therapy
- Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
- Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
- Any vaccination within 8 weeks prior to the first dose of study drug
- Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
- Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
- Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
- More than one change of HAART regimen because of virologic failure

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): NCT02369146
Taiwan | |
Taipei Veterans General Hospital | |
Taipei, Taiwan, 11217 |
Principal Investigator: | Wing Wai Wong, M.D. | Taiwan, Taipei Veterans General Hospital | |
Principal Investigator: | Yen Hsu Chen, M.D. PhD. | Kaohsiung Medical University Chung-Ho Memorial Hospital | |
Principal Investigator: | Hung Chin Tsai, M.D. PhD. | Taiwan, Kaohsiung Veterans General Hospital |
Responsible Party: | United BioPharma |
ClinicalTrials.gov Identifier: | NCT02369146 |
Other Study ID Numbers: |
UBP-A202-HIV |
First Posted: | February 23, 2015 Key Record Dates |
Last Update Posted: | October 31, 2017 |
Last Verified: | October 2017 |
UB-421 Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |