Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
| Status: | Archived |
|---|---|
| Conditions: | High Cholesterol, HIV / AIDS, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
| End Date: | December 2010 |
Changes in Lipid Profiles and Safety of Raltegravir Based Antiretroviral Therapy in HIV-1-Infected Patients With Hyperlipidemia While on Current Standard Therapy
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:
1. Patients with elevated lipid levels while on combination antiretroviral therapy with
PIs or NNRTIs will experience an improvement in lipid levels after switching their PI
or NNRTI to a raltegravir based regimen.
2. Raltegravir will be safe and well tolerated.
3. Raltegravir will have similar antiretroviral activity compared with the prior regimen.
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.
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:
1. Patients with elevated lipid levels while on combination antiretroviral therapy with
PIs or NNRTIs will experience an improvement in lipid levels after switching their PI
or NNRTI to a raltegravir based regimen.
2. Raltegravir will be safe and well tolerated.
3. Raltegravir will have similar antiretroviral activity compared with the prior regimen.
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.
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