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

An Expanded Compassionate Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PRO140_CD02 Study

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02759042
Acronym
CD02_EA
Enrollment
Unknown
Registered
2016-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief summary

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

Detailed description

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.

Interventions

DRUGPRO 140

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

Sponsors

CytoDyn, Inc.
Lead SponsorINDUSTRY
Amarex Clinical Research
CollaboratorOTHER

Eligibility

Sex/Gender
MALE
Age
55 Years to 56 Years

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026