An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

NCT02990858 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-11-12

Study results available
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Summary

PRO 140\_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DRUG

PRO 140

PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5). Participants received 350 or 700 mg weekly injections of PRO 140.

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD · CytoDyn, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2022-06-30
Completion
2022-07-10
FDA Drug
Yes

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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 NCT02990858 on ClinicalTrials.gov