Clinical Trials

MainTitle

Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients

This study has been completed
Sponsor
Southern California Institute for Research and Education

Collaborator
Pfizer

Information provided by (Responsible Party)
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier
NCT02934022

First received: June 4, 2012
Last updated: October 13, 2016
Last Verified: October 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection

Drug : Maraviroc

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adding Maraviroc to the HAART Regimen of HIV-infected Patients Who Are Well Controlled, and the Effect on CD4 Lymphocyte Counts

Further study details as provided by Southern California Institute for Research and Education:

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. [ Time Frame: one year ]

Enrollment: 25
Study Start Date: June 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Maraviroc

Drug: Maraviroc

150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)

Other Name: Selzentry

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. HIV-1 positive.
    2. Receiving highly active antiretroviral therapy (HAART).
    3. HIV-1 viral load of < 48 copies for 12 months or more.
    4. CD4 lymphocyte count that has not gone above 500. -


Exclusion Criteria:
    1. Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases > 5 times normal.
    2. Severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
    3. Receiving certain necessary medications that have the potential for serious drug-drug
    interactions with maraviroc. -

contacts and locations

Contacts and Locations

Choosing 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: NCT02934022

Locations

United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822

Sponsors and Collaborators

Southern California Institute for Research and Education
Pfizer

Investigators

Principal Investigator: Stephen M. Berman, MD, PhD VA Long Beach Healthcare System
More Information

More Information


Responsible Party: Southern California Institute for Research and Education  
ClinicalTrials.gov Identifier: NCT02934022   History of Changes  
Other Study ID Numbers: WS719742  
Study First Received: June 4, 2012  
Last Updated: October 13, 2016  

Keywords provided by Southern California Institute for Research and Education:

Maraviroc
HAART regimen
Immunologic response

Additional relevant MeSH terms:
HIV Infections
Maraviroc

ClinicalTrials.gov processed this data on September 17, 2019
This information is provided by ClinicalTrials.gov.