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Sponsors and Collaborators: |
University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI) Pfizer |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00844519 |
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.
Condition | Intervention | Phase |
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HIV Infection Endothelial Function Cardiovascular Disease Inflammation HIV Infections |
Drug: Maraviroc Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Maraviroc: Active Comparator
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
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Drug: Maraviroc
For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
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Placebo: Placebo Comparator |
Drug: placebo
For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Priscilla Hsue, MD | 4152068257 | phsue@medsfgh.ucsf.edu |
Contact: Amanda Schnell, BA | 4152065461 | aschnell@medsfgh.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94110 |
Responsible Party: | Univeristy of California, San Francisco ( Priscilla Hsue/Assistant Professor of Medicine ) |
Study ID Numbers: | HIVCADRFA |
Study First Received: | February 13, 2009 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00844519 History of Changes |
Health Authority: | United States: Institutional Review Board |
Treatment Experienced CCR5 receptor maraviroc |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Inflammation |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Inflammation Virus Diseases Pathologic Processes HIV Infections Sexually Transmitted Diseases Lentivirus Infections Cardiovascular Diseases Retroviridae Infections |