NCT02369146

To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: United BioPharma · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

Detailed description

This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-02-23
• Last updated: 2017-10-31

Locations

1 site across 1 country: Taiwan