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An Extension of Protocol PRO 140_CD01 TS Study

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ClinicalTrials.gov Identifier: NCT02355184
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 4, 2015
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
Time to virologic failure after initiating PRO 140 monotherapy. [ Time Frame: 25 weeks ]
Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.
Change History Complete list of historical versions of study NCT02355184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to160 weeks ]
  • Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 160 weeks ]
  • Mean change in CD4 cell count [ Time Frame: Up to 160 weeks ]
  • Change in Quality of Life metrics (up to TE107) [ Time Frame: Up to 160 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to 25 weeks ]
  • Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 25 weeks ]
  • Mean change in CD4 cell count [ Time Frame: Up to 25 weeks ]
  • Change in Quality of Life metrics [ Time Frame: Up to 25 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2016)
  • 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 ]
  • Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 160 weeks ]
  • Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 160 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: January 30, 2015)
  • 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 25 weeks ]
  • Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 25 weeks ]
  • Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 25 weeks ]
 
Descriptive Information
Brief Title  ICMJE An Extension of Protocol PRO 140_CD01 TS Study
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Human Immunodeficiency Virus
Intervention  ICMJE Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist
Other Name: PRO 140
Study Arms  ICMJE Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Intervention: Drug: PRO 140 350mg weekly SQ injection.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2015)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02355184
Other Study ID Numbers  ICMJE PRO 140_CD 01-Extension
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytoDyn, Inc.
Study Sponsor  ICMJE CytoDyn, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoDyn, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP