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Sponsors and Collaborators: |
The Miriam Hospital Tufts Medical Center Merck |
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Information provided by: | The Miriam Hospital |
ClinicalTrials.gov Identifier: | NCT00887653 |
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.
The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited.
Hypotheses:
Primary Objective:
To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.
Study Design: Subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the study for 6 months. At entry, the subjects will undergo a complete physical exam and thereafter targeted exams at each visit.
Labs will be drawn as part of clinical care at 2, 3, and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be compared before and after the study. At the end of the study, the participants may choose to continue on raltegravir if they desire.
Condition | Intervention | Phase |
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HIV Hyperlipidemia Hypertriglyceridemia |
Drug: raltegravir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Changes in Lipid Profiles and Safety of Raltegravir Based Antiretroviral Therapy in HIV-1-Infected Patients With Hyperlipidemia While on Current Standard Therapy |
Estimated Enrollment: | 20 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
The success of combination antiretroviral therapy heralded a revolution in the management of patients with HIV in the mid-1990s. Increasingly, severe treatment-associated metabolic side effects have been observed and linked to premature coronary artery disease. This effect has been described among many regimens containing protease inhibitors (PIs) as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Raltegravir is a novel HIV-1 integrase inhibitor which in a comparison study with efavirenz has been shown to be potent and efficacious in suppression of the HIV-1. Minimal side effects were reported which mainly included nausea, headache, dizziness, diarrhea, and insomnia.
Hypotheses:
Primary Objective:
To demonstrate an improvement in triglycerides or LDL in subjects switched to raltegravir from PIs or NNRTIs at 2 months, 3 months, and 6 months after study entry.
Secondary Objectives:
To assess the immunologic and virologic outcomes in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after entry.
Study Design:
This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Primary endpoint: Change from baseline LDL and change from baseline triglycerides at 3 months, adjusted for BMI and smoking status.
The subjects' plasma viral load before and after switching will be compared with a paired t test at each time point.
The subjects' CD4+ T cell count will be compared with a paired t test before and after switching.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carolina E Abuelo, MD | 401 793 4640 | cabuelo@lifespan.org |
Contact: Karen Tashima, MD | 401 7934089 | ktashima@lifespan.org |
United States, Massachusetts | |
Tufts University | |
Boston, Massachusetts, United States, 02111 | |
United States, Rhode Island | |
Miriam Hospital Immunology Clinic | |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Karen Tashima, MD | The Miriam Hospital |
Responsible Party: | Miriam Hospital ( Dr. Karen Tashima ) |
Study ID Numbers: | 2007-09 |
Study First Received: | April 23, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00887653 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Hypertriglyceridemia Hyperlipidemias HIV Infections |
Acquired Immunodeficiency Syndrome Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |