Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Condition: Hyperlipidemia; HIV
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Pitavastatin; Darunavir; Ritonavir; Efavirenz
Intervention description: Pitavastatin 2 mg tablets taken at bedtime in Arm A and in the morning in Arm B.; Darunavir 400 mg tablets x 2 taken daily in Arm B; Ritonavir 100 mg tablets taken daily in Arm B; Efavirenz 600 mg tablets taken at bedtime in Arm A
Intervention MeSH terms: Ritonavir; Darunavir; Efavirenz; Pitavastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; Hyperlipidemia; Pharmacokinetics; Statins; Darunavir; Efavirenz; Pitavastatin

Summary:

      The main goal of this study is to determine how taking efavirenz affects the levels of
      pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir
      with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to
      see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are
      taken together and to see how taking pitavastatin affects the levels in the blood of
      darunavir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days
             prior to study entry.

          -  Male or female aged 18-60 years.

          -  Able and willing to provide informed consent.

          -  All men and women of reproductive potential must practice adequate birth control to
             prevent pregnancy from start of the study until completion of the study.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 14 days prior to study entry and day of entry.

          -  Hemoglobin > 12.5 g/dL for men; > 11.5 g/dL for women;

          -  Absolute neutrophil count >1,500 cells/mm3;

          -  Platelet count > 100,000 platelets/mm3;

          -  AST (SGOT)/ALT (SGPT) <1.5X ULN;

          -  Creatinine <1.5 X ULN

          -  Subject is within 20% (+/-) of ideal body weight and must weigh at least 50 kg

        Exclusion Criteria:

          -  Use of illicit drugs or alcohol which would interfere with the completion of this
             study.

          -  Pregnancy or breast-feeding.

          -  History of chronic illnesses such as hypertension, coronary artery disease, arthritis,
             diabetes, or any chronic gastrointestinal conditions which might interfere with drug
             absorption.

          -  Any medical condition which, in the opinion of the investigator, would interfere with
             the subjects ability to participate in this protocol.

          -  Use of prohibited protocol-specified drugs, prescription or over-the-counter within 14
             days prior to study entry.

          -  Participation in any investigational drug studies within 30 days prior to study entry.