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Sponsors and Collaborators: |
Kaiser Permanente Merck |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00529243 |
The primary objective of this study is:
• To assess the virologic effect of changing enfuvirtide to MK-0518 in HIV-1 infected patients who have an undetectable level of serum HIV (< 75 copies/ml by bDNA assay, < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.
Hypothesis:
HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Raltegravir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen |
Estimated Enrollment: | 50 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Open label, single arm. All patients to receive MK-0518 400mg PO BID for 24 weeks, as substitution for enfuvirtide.
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Drug: Raltegravir
This is a single-arm, open-label, non-randomized pilot study in HIV-1 positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV RNA below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
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HIV-1 infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 400mg PO BID as substitution for enfuvirtide for 24 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
Subject has any of the following laboratory results at screening:
Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min
United States, California | |
Kaiser Los Angeles | |
Los Angeles, California, United States, 90027 | |
Kaiser Hayward | |
Hayward, California, United States, 95454 | |
Kaiser San Francisco | |
San Francisco, California, United States, 94118 | |
Kaiser Santa Clara | |
Santa Clara, California, United States, 95051 | |
Kaiser West Los Angeles | |
Los Angeles, California, United States, 90034 | |
Kaiser Anaheim | |
Anaheim, California, United States, 92807 | |
Kaiser Panorama City | |
Panorama City, California, United States, 91402 | |
Kaiser Santa Clarita | |
Santa Clarita, California, United States, 91355 |
Principal Investigator: | William J Towner, MD | Kaiser Permanente |
Responsible Party: | Kaiser Permanente ( William Towner, MD ) |
Study ID Numbers: | 4908 |
Study First Received: | September 12, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00529243 |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Enfuvirtide Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Infection |
Antiviral Agents Pharmacologic Actions Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections HIV Fusion Inhibitors |