Trial record 3 of 12 for:    PRO-140

An Extension of Protocol PRO 140_CD01 TS Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by CytoDyn, Inc.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT02355184
First received: January 30, 2015
Last updated: February 19, 2016
Last verified: February 2016
  Purpose

This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure.

Consenting patients will continue to receive PRO 140 monotherapy for 108 additional weeks. Total treatment duration with PRO 140 will be up to 109 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.


Condition Intervention Phase
HIV
Human Immunodeficiency Virus
Drug: PRO 140 350mg weekly SQ injection.
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 (Monoclonal CCR5 Antibody) Monotherapy for Additional 108 Weeks in Adult Subjects w/ HIV-1

Resource links provided by NLM:


Further study details as provided by CytoDyn, Inc.:

Primary Outcome Measures:
  • Time to virologic failure after initiating PRO 140 monotherapy. [ Time Frame: 108 weeks ] [ Designated as safety issue: Yes ]
    Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.


Secondary Outcome Measures:
  • Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
  • Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
  • Mean change in CD4 cell count [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
  • Change in Quality of Life metrics [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants(using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: November 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist
Other Name: PRO 140

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
  2. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug.
  3. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

  1. Not currently enrolled in PRO140_CD01 Treatment Substitution Study
  2. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
  3. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
  4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  5. Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
  6. Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements
  7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02355184

Contacts
Contact: Kush Dhody, MBBS, MS (301)956-2536 kushd@amarexcro.com

Locations
United States, California
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: Jacob Lalezari, MD    415-353-0762      
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
Principal Investigator: Jacob Lalezari, MD
  More Information

Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02355184     History of Changes
Other Study ID Numbers: PRO 140_CD 01-Extension 
Study First Received: January 30, 2015
Last Updated: February 19, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
PRO-140 monoclonal antibody
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Antibodies
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016