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Sponsors and Collaborators: |
Johns Hopkins University Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00344123 |
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 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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tipranavir Drug: Ritonavir Drug: Rosuvastatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Evaluation of Single-Dose Rosuvastatin 10 mg When Co-Administered With Steady-State Tipranavir 500 mg/Ritonavir 200 mg TPV/r) B.I.D. in Healthy Adult Volunteers |
Estimated Enrollment: | 23 |
Study Start Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women of childbearing potential (WOCBP) must not be nursing or pregnant. All women of childbearing potential (have not reached menopause nor undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum beta-HCG test performed at screening (within 24 hours before the start of study day 1). Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable. Both male and female study volunteers of reproductive potential must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate via sperm donation or in vitro fertilization), and, if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use a form of contraception as specified below while receiving protocol-specified medication(s) and for one month after stopping the medication(s). Male study volunteers will be required to use a barrier method for at least 3 months after completion of the study.
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Paul Pham, PharmD | Johns Hopkins University |
Study ID Numbers: | NA_00003633 |
Study First Received: | June 22, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00344123 |
Health Authority: | United States: Food and Drug Administration |
HIV |
Virus Diseases Sexually Transmitted Diseases, Viral Rosuvastatin Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes Tipranavir |
Antimetabolites Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |