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Sponsors and Collaborators: |
University of California, San Francisco Merck |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00631449 |
The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.
Condition | Intervention |
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HIV Infections |
Drug: Raltegravir Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Raltegravir Intensification in Antiretroviral-Treated Patients Exhibiting a Suboptimal CD4+ T Cell Response |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Raltegravir: Active Comparator
For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
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Drug: Raltegravir
For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.
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Placebo: Placebo Comparator
For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
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Drug: Placebo
For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
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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: Hiroyu Hatano, MD | (415) 476-4082 ext 122 | hhatano@php.ucsf.edu |
Contact: Steven G. Deeks, MD | (415) 476-4082 ext 404 | sdeeks@php.ucsf.edu |
United States, California | |
San Francisco General Hospital, Clinical Research Center | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu | |
Contact: Steven G. Deeks, MD (415) 476-4082 ext 404 sdeeks@php.ucsf.edu | |
Principal Investigator: Hiroyu Hatano, MD | |
San Francisco Veterans Affairs Medical Center | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu | |
Contact: Steven G. Deeks, MD (415) 476-4082 ext 404 sdeeks@php.ucsf.edu | |
Principal Investigator: Harry Lampiris, MD |
Principal Investigator: | Hiroyu Hatano, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Hiroyu Hatano, MD/Principal Investigator ) |
Study ID Numbers: | H52899-31393-01 |
Study First Received: | February 28, 2008 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00631449 |
Health Authority: | United States: Institutional Review Board |
HIV Treatment intensification Low level viremia Suboptimal CD4+ T cell response 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 |