Loading clinical trials...

COMPLETEDPHASE2

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients

NCT03743376•United BioPharma

View on ClinicalTrials.gov

Summary

This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients

Eligibility

Age

20 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. HIV-1 sero-positive
•2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
•3. HIV-1 plasma RNA level below 50 RNA copies/mL .

Exclusion Criteria

•1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
•2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
•3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
•4. History of anaphylaxis to other mAbs.
•5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
•6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
•7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Locations (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Key Dates

Start Date

December 12, 2018

Primary Completion Date

October 15, 2020

Completion Date

December 31, 2021

Last Updated

May 13, 2022

Enrollment

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

UB-421(25 mg/kg) Q2W

BIOLOGICAL

UB-421(25 mg/kg) Q4W

BIOLOGICAL

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients