Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
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.