Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

NCT01140126

HIV-1 Infection in Adults (Asymptomatic)

COMPLETED PHASE1

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

NCT04620304

HIV-1 Infection

COMPLETED PHASE1

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

NCT03743376

HIV-1 Infection

COMPLETED PHASE2

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

NCT04404049

HIV-1-infection

UNKNOWN PHASE2

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults

NCT04620291

HIV-1-infection

NOT_YET_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1 Infection in Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Antibody UB-421 Cohort 1

10 mg/kg BW, 8 weekly doses for 8-week treatment period

Group Type EXPERIMENTAL

Antibody UB-421

Intervention Type DRUG

UB-421 is administered by intravenous infusion

Antibody UB-421 Cohort 2

25 mg/kg BW, 4 biweekly doses for 8-week treatment period

Group Type EXPERIMENTAL

Antibody UB-421

Intervention Type DRUG

UB-421 is administered by intravenous infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antibody UB-421

UB-421 is administered by intravenous infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Asymptomatic, treatment-naive, HIV-1 seropositive
* CD4+ T cell count \>350 cells/cubic millimeter
* HIV-1 viral load \>5,000 copies/mL

Exclusion Criteria

* Active infection requiring immediate therapy (except HIV-1)
* Previous exposure to monoclonal antibody (including UB-421)
* Prior participation in any HIV vaccine trial
* Use of immunomodulating drugs or systemic chemotherapy

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No