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

NCT02934022

Last updated date
Study Location
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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. -

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Advanced Information
Descriptive Information
Brief Title  ICMJE Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients
Official Title  ICMJE Adding Maraviroc to the HAART Regimen of HIV-infected Patients Who Are Well Controlled, and the Effect on CD4 Lymphocyte Counts
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE Drug: Maraviroc
150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)
Other Name: Selzentry
Study Arms  ICMJE Maraviroc
Intervention: Drug: Maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2016)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02934022
Other Study ID Numbers  ICMJE WS719742
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southern California Institute for Research and Education
Study Sponsor  ICMJE Southern California Institute for Research and Education
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Stephen M. Berman, MD, PhDVA Long Beach Healthcare System
PRS Account Southern California Institute for Research and Education
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP