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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	HIV Infection
Interventions:	Drug: Placebo; Drug: Maraviroc

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the HIV clinics at San Francisco General Hospital, Stanford University, Case Western Reserve University, and Rush University/CORE Center between September, 2008, and December, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 45 enrolled patients were assigned to study intervention. We over-enrolled by 3 subjects given 2 premature treatment discontinuations and one subject with unavailable baseline peripheral blood mononuclear cell (PBMC) samples available for analysis.

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).

Participant Flow:   Overall Study

	Maraviroc	Placebo
STARTED	23	22
COMPLETED	22	21
NOT COMPLETED	1	1
interrupted study med during ARV change	1	0
Subject interrupted ARVs (non-adherence)	0	1

  Baseline Characteristics

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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.
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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 ]

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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

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  Other Adverse Events

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  Limitations and Caveats

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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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