Back to resultsAn Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Primary Purpose
Hiv, Human Immunodeficiency Virus
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PRO 140 SC injections
Sponsored by
About this trial
This is an interventional treatment trial for Hiv
Eligibility Criteria
Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.
- 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
- HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study
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.
- 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.
- Not currently enrolled in PRO 140_CD 02 study
- Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRO 140
Arm Description
Outcomes
Primary Outcome Measures
Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period
Secondary Outcome Measures
Mean change in CD4 cell count at the conclusion of treatment period
Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions
Frequency of treatment-related adverse events resulting in study drug discontinuation
Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale
Frequency of treatment-emergent serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02990858
Brief Title
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Official Title
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoDyn, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRO 140
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRO 140 SC injections
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Mean change in CD4 cell count at the conclusion of treatment period
Time Frame
through study completion, an average of 4 year
Title
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
Title
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
Title
Frequency of treatment-related adverse events resulting in study drug discontinuation
Time Frame
through study completion, an average of 4 year
Title
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
Title
Frequency of treatment-emergent serious adverse events
Time Frame
through study completion, an average of 4 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.
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
HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study
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.
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.
Not currently enrolled in PRO 140_CD 02 study
Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
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