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Compassionate Use of Ibalizumab for the Treatment of HIV Infection

NCT02028819 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2016-11-01

No results posted yet for this study

Summary

Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DRUG

Dolutegravir Sodium Monohydrate

Dolutegravir taken 50mg orally twice daily

DRUG

Ibalizumab

Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Edward M Gardner, M.D. · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028819 on ClinicalTrials.gov