Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
Condition: HIV; Hyperlipidemia; Hypertriglyceridemia; HIV Infections
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Intervention: raltegravir
Intervention description: 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.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18

          -  Fasting LDL>130 mg/dL

          -  Fasting triglycerides >250 mg/dL

          -  Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study
             entry.

          -  No prior history of any NRTI resistance.

        Exclusion Criteria:

          -  History of NRTI resistance mutations

          -  Need for medications that have drug interactions with raltegravir: dilantin,
             phenobarbitol and rifampin

          -  Unstable clinical condition, such as unstable cardiac disease, or cancer requiring
             ongoing chemotherapy or radiation therapy, or other medical condition which, in the
             opinion of the investigator, would preclude a subject from safely undergoing study
             procedures.

          -  Breast-feeding or pregnancy.

          -  Use of immunosuppressive medications within 60 days prior to study entry.

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements.