An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Information provided by (Responsible Party)
First received: November 17, 2016
Last updated: December 8, 2016
Last Verified: December 2016
History of Changes
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.
Human Immunodeficiency Virus
Drug : PRO 140 SC injections
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study|
Further study details as provided by CytoDyn, Inc.:
Primary Outcome Measures
- 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 ]
- 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 ]
|Study Start Date:||October 2016|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
PRO 140 SC injections
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
Contacts and LocationsChoosing 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: NCT02990858
Sponsors and CollaboratorsCytoDyn, Inc.
|Responsible Party:||CytoDyn, Inc.|
|ClinicalTrials.gov Identifier:||NCT02990858 History of Changes|
|Other Study ID Numbers:||PRO 140 _CD02 Extension|
|Study First Received:||November 17, 2016|
|Last Updated:||December 8, 2016|
|Individual Participant Data|
|Plan to Share IPD:||Undecided|
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
PRO-140 monoclonal antibody
ClinicalTrials.gov processed this data on July 09, 2020
This information is provided by ClinicalTrials.gov.