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

History of Changes

Results First Received: June 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, 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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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
Number of Participants [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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Measure Type	Primary
Measure Title	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)
Measure Description	No text entered.
Time Frame	Week 24
Safety Issue	No

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).

Measured Values

	Maraviroc	Placebo
Number of Participants Analyzed [units: participants]	23	22
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) [units: %CD38+ HLA-DR+ CD8+ T cells] Median ( Inter-Quartile Range )	2.2 ( -0.6 to 4.1 )	-0.7 ( -3.5 to 0.6 )

Statistical Analysis 1 for 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)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.014

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary:

Change in CD4+ T Cell Count [ Time Frame: Week 24 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay) [ Time Frame: Week 24 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only) [ Time Frame: Week 24 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only) [ Time Frame: Week 24 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
No text entered.

Results Point of Contact:

Name/Title: Peter W. Hunt, MD
Organization: UCaliforniaSF
phone: (415) 476-4082 ext 345
e-mail: phunt@php.ucsf.edu

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00735072 History of Changes
Other Study ID Numbers:	GA9001DE
Study First Received:	August 12, 2008
Results First Received:	June 5, 2011
Last Updated:	June 13, 2012
Health Authority:	United States: Institutional Review Board

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