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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00515827 |
Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs. The purpose of this study is to assess the effectiveness of raltegravir in further reducing viral load in HIV infected patients that have already achieved viral suppression below the level of detection of standard viral load assays when added to antiretroviral therapy (ART).
Condition | Intervention | Phase |
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HIV Infections |
Drug: Raltegravir (MK-0518) Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification With a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia Below 50 Copies/ml in Subjects on Protease Inhibitor- or Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimens |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
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Drug: Raltegravir (MK-0518)
400 mg tablet taken orally twice daily
Drug: Placebo
400 mg placebo tablet taken orally twice daily
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Arm B: Experimental
Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks
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Drug: Placebo
400 mg placebo tablet taken orally twice daily
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Although ART has reduced the morbidity and mortality from HIV-1 infection, most individuals who stop ART experience rapid viral rebound. Effective ART can suppress viral load to less than 50 copies/ml; however, current treatment regimens can not completely eliminate the infection. The primary purpose of this study is to assess the ability of the HIV-1 integrase inhibitor, raltegravir, to reduce viral load when added to ART regimens of HIV-1 infected patients who have achieved viral suppression to less than 50 copies/ml.
The study will last 24 weeks. Participants will be randomly stratified to one of two arms. Participants in Arm A will be administered raltegravir in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects will halt raltegravir use and receive a placebo until Week 24. Participants in Arm B will be administered the placebo in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects will halt the placebo and receive raltegravir until Week 24. A real-time polymerase chain reaction (PCR) single copy assay (SCA) capable of detecting 1 copy/ml of HIV RNA will be used to assay viral load. The cross-over design allows assessment of the effect of intensification with raltegravir between the two arms at Weeks 10 and 12 and assessment of viral rebound after discontinuation of raltegravir in Arm A.
All participants will have scheduled visits at Weeks 0, 2, 4, 10, 12, 14, 16, 22, and 24. A targeted physical exam and blood and urine collection will occur at all visits. A medical/medication assessment will occur at trial entry. Drug dispensing and an adherence questionnaire will occur at some visits. A pregnancy test will occur at select visits. Participants' current ART medications will not be provided by the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham, 1917 Research Clinic | |
Birmingham, Alabama, United States, 35924 | |
United States, California | |
Stanford University School of Medicine, ACTU | |
Stanford, California, United States, 94305 | |
Harbor - UCLA Medical Center, LA Biomedical Research Institute | |
Torrance, California, United States, 90502 | |
UCSF PHP, San Francisco General Hospital | |
San Francisco, California, United States, 94110 | |
United States, Georgia | |
Emory Universtiy, Infectious Disease Program | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Northwestern University Clinical Research Site | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Mass. General Hospital, Division of Infectious Diseases | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hopsital, Division of Infectious Disease | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center; ACTG | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine, ACTU | |
St. Louis, Missouri, United States, 63108 | |
United States, New York | |
Weill Med College of Cornell Univ., The Cornell CTU-Chelsea | |
New York, New York, United States, 10011 | |
NYU Medical Center | |
New York, New York, United States, 10016 | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
AIDS Community Health Center | |
Rochester, New York, United States, 14642 | |
Columbia Univ., HIV Prevention and Treatment Research Group | |
New York, New York, United States, 10032 | |
Harlem ACTG CRS | |
New York, New York, United States, 10037 | |
United States, North Carolina | |
Duke University School of Medicine, Div. of Infectious Diseases | |
Durham, North Carolina, United States, 27710 | |
The Moses H. Cone Memorial Hospital, Internal Medicine Training Program | |
Greensboro, North Carolina, United States, 27401 | |
United States, Ohio | |
Case Western Reserve University, ACTU | |
Cleveland, Ohio, United States, 44106 | |
MetroHealth Medical Center; ACTG | |
Cleveland, Ohio, United States, 44109 | |
United States, Oregon | |
The Research and Education Group - Portland CRS | |
Portland, Oregon, United States, 97209 | |
United States, Pennsylvania | |
University of Pittsburgh, ACTU | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Rajesh T Gandhi, MD | Massachusetts General Hospital |
Study Director: | Joseph J Eron Jr., MD | The University of North Carolina, Chapel Hill |
Study Director: | John W Mellors, MD | University of Pittsburgh |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5244, A5244 |
Study First Received: | August 10, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00515827 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Viremia Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |