Trial record 3 of 11 for:    PRO-140

Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

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:
NCT02175680
First received: June 24, 2014
Last updated: February 19, 2016
Last verified: February 2016
  Purpose

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment 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: A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection

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. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 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: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: May 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (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

  Eligibility

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

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
  3. On stable antiretroviral therapy for last 12 months
  4. Subject has two or more potential alternative antiretroviral regimen options to consider.
  5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit
  6. Nadir CD4 cell count of >200 cells/mm3

Exclusion Criteria:

  1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
  3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
  4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
  5. 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: NCT02175680

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

Locations
United States, California
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: Kush Dhody    301-956-2536    kushd@amarexcro.com   
Principal Investigator: Jacob Lalezari, MD         
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
Principal Investigator: Jacob Lalezari, MD
  More Information

Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02175680     History of Changes
Other Study ID Numbers: PRO 140_CD 01 
Study First Received: June 24, 2014
Last Updated: February 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by CytoDyn, Inc.:
HIV-1
HIV
Treatment Substitution
PRO 140
PRO140
CytoDyn
Amarex

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 July 28, 2016