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An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 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.
 
ClinicalTrials.gov Identifier: NCT02990858
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period [ Time Frame: through study completion, an average of 4 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Mean change in CD4 cell count at the conclusion of treatment period [ Time Frame: through study completion, an average of 4 year ]
  • Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry. [ Time Frame: through study completion, an average of 4 year ]
  • Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions [ Time Frame: through study completion, an average of 4 year ]
  • Frequency of treatment-related adverse events resulting in study drug discontinuation [ Time Frame: through study completion, an average of 4 year ]
  • Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: through study completion, an average of 4 year ]
  • Frequency of treatment-emergent serious adverse events [ Time Frame: through study completion, an average of 4 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Official Title  ICMJE An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Brief Summary This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hiv
  • Human Immunodeficiency Virus
Intervention  ICMJE Drug: PRO 140 SC injections
Study Arms  ICMJE Experimental: PRO 140
Intervention: Drug: PRO 140 SC injections
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 8, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.

  1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression
  2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study
  3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (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.

  4. 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: Potential subjects meeting any of the following criteria will be excluded from enrollment.

  1. Not currently enrolled in PRO 140_CD 02 study
  2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
  3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  4. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990858
Other Study ID Numbers  ICMJE PRO 140 _CD02 Extension
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CytoDyn, Inc.
Study Sponsor  ICMJE CytoDyn, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoDyn, Inc.
Verification Date December 2016

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