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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00884793 |
The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification.
These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .
Condition | Intervention |
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HIV Infections |
Drug: raltegravir |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Prospective Longitudinal Pilot Study to Measure the Effect of Therapy Intensification With Raltegravir +/- a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor on HIV-1 DNA and RNA in the Gut-Associated Lymphoid Tissue (GALT) in Patients on Suppressive Antiretroviral Therapy |
Estimated Enrollment: | 12 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
intensification with raltegravir +/- PI or NNRTI
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Drug: raltegravir
The baseline ART regimen will be intensified with raltegravir 400mg PO BID (all participants) +/- a study NNRTI or PI (at the option of the participant and the study clinical team).
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The "PLUS" study is a prospective, longitudinal pilot study to measure the effect of therapy intensification (with raltegravir and possible addition of a study PI or NNRTI) on HIV-1 DNA/RNA levels in the gut-associated lymphoid tissue (GALT) and blood in patients on ART with viral load (VL) < 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the GALT despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have a colonoscopy and esophagogastroduodenoscopy (EGD) at baseline (before intensification) and a second colonoscopy with EGD 12 weeks after intensification. These endoscopies will be used to obtain GALT mononuclear cells (for CD4+ lymphocytes) as well as tissue for in situ hybridization and immunohistochemical studies.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any condition that, in the opinion of the GI specialist, would either be a contraindication to endoscopy or would increase the risk from sedation, endoscopy, or mucosal biopsies. These conditions may include, but are not limited to:
Contact: Steven Yukl, MD | 415-221-4810 ext 3930 | steven.yukl@ucsf.edu |
United States, California | |
San Francisco VA Medical Center (SFVAMC) | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Steven Yukl, MD | |
Principal Investigator: Joseph K Wong, MD | |
Principal Investigator: Steven Yukl, MD | |
San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Steven Yukl, MD | |
Principal Investigator: Diane V Havlir, MD |
Principal Investigator: | Diane Havlir, MD | San Francisco General Hospital (SFGH) and University of California San Francisco (UCSF) |
Principal Investigator: | Joseph K Wong, MD | San Francisco VA Medical Center (SFVAMC) and University of California, San Francisco (UCSF) |
Principal Investigator: | Steven Yukl, MD | SFVMAC and UCSF |
Responsible Party: | SFGH and UCSF ( Diane V. Havlir ) |
Study ID Numbers: | PLUS1 |
Study First Received: | April 20, 2009 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00884793 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV persistence reservoirs residual replication |
gut gut-associated lymphoid tissue treatment experienced |
Virus Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |