Clinical Trials

MainTitle

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

This study has been completed
Sponsor
CytoDyn, Inc.


Information provided by (Responsible Party)
CytoDyn, Inc.
ClinicalTrials.gov Identifier
NCT02175680

First received: June 24, 2014
Last updated: December 14, 2016
Last Verified: December 2016
History of Changes
Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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

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

Enrollment: 43
Study Start Date: May 2014
Study Completion Date: September 2016
Primary Completion Date: September 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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

Locations

United States, California
Quest Clinical Research
San Francisco, California, United States, 94115

Sponsors and Collaborators

CytoDyn, Inc.

Investigators

Principal Investigator: Jacob Lalezari, MD
More Information

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: December 14, 2016  

Keywords provided by CytoDyn, Inc.:

HIV-1
HIV
Treatment Substitution
PRO 140
PRO140
CytoDyn
Amarex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
PRO-140 monoclonal antibody
HIV Antibodies

ClinicalTrials.gov processed this data on November 22, 2019
This information is provided by ClinicalTrials.gov.