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An Extension of Protocol PRO 140_CD01 TS Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02355184
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : September 29, 2021
Information provided by (Responsible Party):
CytoDyn, Inc.

Brief Summary:

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 160 additional weeks. Total treatment duration with PRO 140 will be up to 161 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 or disease Intervention/treatment Phase
HIV Human Immunodeficiency Virus Drug: PRO 140 350mg weekly SQ injection. Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 160 Weeks in Adult Subjects w/ HIV-1
Actual Study Start Date : November 18, 2014
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist
Other Name: PRO 140

Primary Outcome Measures :
  1. Time to virologic failure after initiating PRO 140 monotherapy. [ Time Frame: 160 weeks ]
    Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.

Secondary Outcome Measures :
  1. Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to160 weeks ]
  2. Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 160 weeks ]
  3. Mean change in CD4 cell count [ Time Frame: Up to 160 weeks ]
  4. Change in Quality of Life metrics (up to TE107) [ Time Frame: Up to 160 weeks ]

Other Outcome Measures:
  1. 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 160 weeks ]
  2. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 160 weeks ]
  3. Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 160 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02355184

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United States, California
CD01-Extension Investigational Site
San Francisco, California, United States, 94115
Sponsors and Collaborators
CytoDyn, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CytoDyn, Inc. Identifier: NCT02355184    
Other Study ID Numbers: PRO 140_CD 01-Extension
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents