Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Maraviroc, HAART regimen, Immunologic response
Eligibility Criteria
Inclusion Criteria:
- HIV-1 positive.
- Receiving highly active antiretroviral therapy (HAART).
- HIV-1 viral load of < 48 copies for 12 months or more.
- CD4 lymphocyte count that has not gone above 500. -
Exclusion Criteria:
- Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases > 5 times normal.
- Severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
- Receiving certain necessary medications that have the potential for serious drug-drug interactions with maraviroc. -
Sites / Locations
- VA Long Beach Healthcare System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Maraviroc
Arm Description
Outcomes
Primary Outcome Measures
Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.
Secondary Outcome Measures
Full Information
NCT ID
NCT02934022
First Posted
June 4, 2012
Last Updated
October 13, 2016
Sponsor
Southern California Institute for Research and Education
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02934022
Brief Title
Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients
Official Title
Adding Maraviroc to the HAART Regimen of HIV-infected Patients Who Are Well Controlled, and the Effect on CD4 Lymphocyte Counts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California Institute for Research and Education
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained response with viral loads becoming undetectable and staying undetectable, but do not have an increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment regimen of these patients may result in an increase in their CD4 counts. As the patient would be continuing their prior regimen, they will likely continue with full control of viral replication.
Detailed Description
This is a prospective, open-label, non-controlled, non-randomized, single center study of the effect of adding the antiretroviral Maraviroc to the antiretroviral treatment regimen (HAART)of patients who have achieved a sustained virologic response to HAART but have had a sub-adequate immunologic response to treatment. Patients who have had a full virologic response (as defined by HIV-1 viral loads of < 48 copies/mL) for 12 months or more are defined as having a sub-adequate immunologic response if their CD4 lymphocyte count has not gone above 500.
This pilot study will contain up to 30 patients who will be followed over a period of 12 months starting from the date of enrollment and addition of maraviroc to their current highly active antiretroviral therapy regimen. The main outcome to be followed is the CD4 lymphocyte counts at baseline and after 12 months of treatment with the addition of maraviroc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Maraviroc, HAART regimen, Immunologic response
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maraviroc
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry
Intervention Description
150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)
Primary Outcome Measure Information:
Title
Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 positive.
Receiving highly active antiretroviral therapy (HAART).
HIV-1 viral load of < 48 copies for 12 months or more.
CD4 lymphocyte count that has not gone above 500. -
Exclusion Criteria:
Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases > 5 times normal.
Severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
Receiving certain necessary medications that have the potential for serious drug-drug interactions with maraviroc. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M. Berman, MD, PhD
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients
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