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Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure

This study has been completed.
Sponsor:
Collaborators:
Pfizer
amfAR, The Foundation for AIDS Research
Stanford University
Case Western Reserve University
Rush University
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00735072
First received: August 12, 2008
Last updated: June 13, 2012
Last verified: June 2012
Results First Received: June 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: Placebo
Drug: Maraviroc

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Maraviroc Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
Placebo Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
Total Total of all reporting groups

Baseline Measures
   Maraviroc   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   21   44 
>=65 years   0   1   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (8)   50  (10)   50  (9) 
Gender 
[Units: Participants]
     
Female   0   2   2 
Male   23   20   43 
Region of Enrollment 
[Units: Participants]
     
United States   23   22   45 


  Outcome Measures

1.  Primary:   Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)   [ Time Frame: Week 24 ]

2.  Secondary:   Change in CD4+ T Cell Count   [ Time Frame: Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)   [ Time Frame: Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)   [ Time Frame: Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)   [ Time Frame: Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information