An Extension of Protocol PRO 140_CD01 TS Study
Information provided by (Responsible Party)
First received: January 30, 2015
Last updated: February 1, 2017
Last Verified: February 2017
History of Changes
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
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.
Human Immunodeficiency Virus
Drug : PRO 140 350mg weekly SQ injection.
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|
Further study details as provided by CytoDyn, Inc.:
Primary Outcome Measures
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.
- 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 ]
- 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 ]
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
PRO 140 350mg weekly SQ injection.
PRO 140 350mg weekly SQ injection.
Other Name: PRO 140
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
- 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.
- 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.
- Not currently enrolled in PRO140_CD01 Treatment Substitution Study
- Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
- Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
- 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
- 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: NCT02355184
Locations Show More
|United States, California|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
Sponsors and CollaboratorsCytoDyn, Inc.
|Principal Investigator:||Sandra Win, MD|
|Responsible Party:||CytoDyn, Inc.|
|ClinicalTrials.gov Identifier:||NCT02355184 History of Changes|
|Other Study ID Numbers:||PRO 140_CD 01-Extension|
|Study First Received:||January 30, 2015|
|Last Updated:||February 1, 2017|
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
PRO-140 monoclonal antibody
ClinicalTrials.gov processed this data on January 19, 2018
This information is provided by ClinicalTrials.gov.