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
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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