An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study

NCT ID: NCT02759042

Last Updated: 2018-03-13

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

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140\_CD02.

Detailed Description

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This is an open label, single center study designed to provide continued access to PRO 140 to a subject who have completed participation in PRO140\_CD02 and continue to receive clinical benefit.

The subject will receive weekly PRO 140 SC injection along with oral ART regimen during the Treatment Phase. The study treatment (PRO 140 SC injections) will be administered by a qualified medical professional or self-administered by the subject.

Conditions

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HIV

Interventions

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PRO 140

PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

Intervention Type DRUG

Other Intervention Names

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PRO140 CCR5 antagonist Humanized monoclonal antibody to CCR5

Eligibility Criteria

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Inclusion Criteria

This study will recruit one treatment-experienced, HIV-1 infected patient with CCR5-tropic virus, who has participated in PRO 140\_CD02 clinical trial and is continuing to derive clinical benefit from PRO 140 treatment.
Minimum Eligible Age

55 Years

Maximum Eligible Age

56 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Amarex Clinical Research

OTHER

Sponsor Role collaborator

CytoDyn, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin DeJesus, MD, FIDSA

Role: PRINCIPAL_INVESTIGATOR

Orlando Immunology Center

Locations

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CD02 EA Investigational site

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PRO140 CD02_EA

Identifier Type: -

Identifier Source: org_study_id

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