Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral
      treatment regimen for resistant HIV-1 infection in adult patients. Since significant
      cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment,
      effective treatment strategies are critical to prevent long-term cardiovascular events.
      Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is
      unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal
      drug interaction study is needed before this combination can be recommended. This study will
      examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500
      mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered
      to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is
      co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant
      clinical interaction will occur.
    

Detailed description: 
      This is a prospective, open-label pharmacokinetic study in healthy HIV seronegative adults.
      This study will examine the pharmacokinetic interactions between steady-state TPV/r 500
      mg/200 mg B.I.D. and single dose rosuvastatin 10 mg when the drugs are co-administered.

      Rosuvastatin 24 hour pharmacokinetic sampling will be performed on days 1-2 and 12-13.
      Rosuvastatin 48 hr samples will be collected on days 3 and day 14.

      Tipranavir and ritonavir 12 hour pharmacokinetic sampling will be on day 11 and 12.

      Safety assessments (physical examination, vital sign measurements, and clinical laboratory
      tests) will be performed at screening, during the study and prior to discharge. Subjects will
      be continuously monitored for adverse events throughout the duration of the study.

      On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3,
      subjects will receive a combination of TPV 500 mg/RTV 200 mg twice daily for 11 days (Days
      3-13).

      On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with
      TPV/r.
    

Intervention name(s): Tipranavir/Ritonavir; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.; On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r..
Other intervention name(s): Aptivus; Crestor
Intervention MeSH terms: Ritonavir; Tipranavir; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV