Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
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ClinicalTrials.gov Identifier: NCT00735072 |
Recruitment Status
:
Completed
First Posted
: August 14, 2008
Results First Posted
: July 18, 2012
Last Update Posted
: July 18, 2012
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Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications. Blocking the "co-receptor" for HIV might decrease inflammation of the immune system, potentially providing an immune benefit. The goal of the current trial is to determine whether adding maraviroc, a new CCR5 "co-receptor" blocker, decreases inflammation, providing an immune benefit for patients with low CD4 counts despite undetectable viral loads on HIV medications.
In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the study medication will be stopped and all subjects will be followed for 12 more weeks. Blood tests measuring the extent of inflammation, low-level viremia, and immune function will be measured throughout the trial and compared between treatment arms.
Condition or disease | Intervention/treatment | Phase |
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HIV Infection | Drug: Placebo Drug: Maraviroc | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Maraviroc
Maraviroc (dose based on current medications in regimen: 150mg orally (PO) twice daily (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).
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Drug: Maraviroc
Dose based on current medications in regimen: 150mg orally (PO) twice daily (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.
Other Name: Selzentry
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Placebo Comparator: 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).
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Drug: 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.
Other Name: Placebo for Maraviroc
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- 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 ]
- Change in CD4+ T Cell Count [ Time Frame: Week 24 ]
- Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay) [ Time Frame: Week 24 ]
- Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only) [ Time Frame: Week 24 ]
- Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only) [ Time Frame: Week 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Stable antiretroviral therapy for at least 12 months
- Screening CD4+ T cell count below 350 cells/mm3
- All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
- Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA)
- All available plasma HIV RNA levels within past year below the level of detection. Isolated values that are detectable but < 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable.
- > 90% adherence to therapy within the preceding 30 days, as determined by self-report.
- Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Ability and willingness of subject or legal guardian/representative to provide informed consent
Exclusion Criteria:
- Increase in CD4 count of > 100 cells/mm3 in past year.
- Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
- Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
- Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
- HBVsAg+ or active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
- Prior exposure to CCR5 inhibitors
- Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.
- Pregnant or breastfeeding women
- Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735072
United States, California | |
University of California San Francisco - San Francisco General Hospital | |
San Francisco, California, United States, 94110 | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Rush University - Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Peter W Hunt, MD | University of California, San Francisco | |
Principal Investigator: | Steven G Deeks, MD | University of California, San Francisco | |
Principal Investigator: | Nancy Shulman, MD | Stanford University | |
Principal Investigator: | Robert Shafer, MD | Stanford University | |
Principal Investigator: | Michael Lederman, MD | Case Western Reserve University | |
Principal Investigator: | Toyin Adeyemi, MD | Rush University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00735072 History of Changes |
Other Study ID Numbers: |
GA9001DE |
First Posted: | August 14, 2008 Key Record Dates |
Results First Posted: | July 18, 2012 |
Last Update Posted: | July 18, 2012 |
Last Verified: | June 2012 |
Keywords provided by University of California, San Francisco:
HIV infection T cell activation Antiretroviral Therapy CCR5 Maraviroc |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Maraviroc Tipranavir Protease Inhibitors HIV Protease Inhibitors Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers CCR5 Receptor Antagonists Anti-HIV Agents |