Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00885495
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009

April 20, 2009
April 21, 2009
January 2009
June 2009   (final data collection date for primary outcome measure)
To investigate the effect of darunavir/ritonavir on the pharmacokinetics of rosuvastatin. [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885495 on ClinicalTrials.gov Archive Site
  • To investigate the effect of rosuvastatin on the steady state pharmacokinetics of darunavir/ritonavir. [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
  • To compare the change in low-density lipoprotein (LDL) cholesterol with rosuvastatin therapy alone, darunavir/ritonavir therapy alone and with the co-administration of rosuvastatin and darunavir/ritonavir. [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study
The Effects of Darunavir Plus Ritonavir on the Pharmacokinetics and Pharmacodynamics of Rosuvastatin

This is a phase I, open-label, controlled drug interaction study to determine the effects of darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.

Twelve HIV-negative healthy volunteers will be randomized to one of two groups. Group 1 would receive rosuvastatin 10mg daily (Treatment A) in interval 1 for 7 days, followed by a washout period of at least 7 days. In interval 2, darunavir/ritonavir 600/100mg bid (Treatment B) would be administered for 7 days, followed by another 7 day washout period. Lastly, in interval 3 subjects will administer darunavir/ritonavir and rosuvastatin (Treatment C) for total of 7 days. Group 2 will administer Treatment B in interval 1 for 7 days, followed by a washout period of 7 days, then treatment A in interval 2 for 7 days followed by another 7 day washout period. Group 2 would then co-administer rosuvastatin and darunavir/ritonavir for the last 7 days. Intensive PK sampling will be performed on day 7, 21 and 35 following a meal.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: darunavir, ritonavir, rosuvastatin
    darunavir 600 mg twice daily for 7 days ritonavir 100 mg twice daily for 7 days rosuvastatin 10 mg once daily for 7 days Combination of all three drugs for 7 days
    Other Names:
    • Prezista
    • Norvir
    • Crestor
  • Drug: rosuvastatin, darunavir, ritonavir
    rosuvastatin 10 mg daily for 7 days; darunavir 600 mg twice daily for 7 days with ritonavir 100 mg twice daily for 7 days; Combination of all three for 7 days
    Other Names:
    • Prezista
    • Norvir
    • Crestor
  • Active Comparator: B
    Darunavir+ritonavir x 7 days; Rosuvastatin x 7 days; Combination x 7 days
    Intervention: Drug: darunavir, ritonavir, rosuvastatin
  • Active Comparator: A
    Rosuvastatin x 7 days; darunavir+ritonavir x 7 days; Combination x 7 days
    Intervention: Drug: rosuvastatin, darunavir, ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
August 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Absence of HIV-1/HIV-2 infection as documented by a licensed ELISA test kit within 21 days prior to study entry.
  2. Male or female subjects, aged ≥ 18 and ≤ 60 years
  3. Weight ≥50 kg and a Body Mass Index ([BMI], weight in kg divided by the square of height in meters) ≥18.0 and ≤ 35.0 kg/m2. Refer to Appendix I.
  4. Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
  5. Able to comply with protocol requirements.
  6. Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of blood tests and a urinalysis carried out at screening.

Exclusion Criteria:

  1. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures.
  2. Currently active significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease, that in the opinion of the investigator would represent a contraindication to study enrollment.
  3. Creatinine clearance of ≤ 60mL/min.
  4. Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
  5. eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria, that in the opinion of the investigator would represent a contraindication to study enrollment.
  6. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the medications administered in the trial.
  7. History of significant drug allergy such as, but not limited to, sulphonamides and penicillins. Prezista is a sulphonamide. The potential for cross-sensitivity between drugs in the sulphonamide class and Prezista in HIV-negative subjects is unknown.
  8. Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, anti-histamines such as diphenhydramine, inhalers for asthma, daily multivitamins, mineral supplements and hormonal oral contraceptives. Concomitant medication other than those listed above must have been discontinued at least 7 days before study entry.
  9. Female subjects of childbearing potential without use of effective nonhormonal birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period; Note: Estrogen-based hormonal contraception may not be reliable when taking Prezista, therefore to be eligible for this trial, women of childbearing potential should either:

    • use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap);
    • use non-estrogen hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
    • use a intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
    • be not sexually active, or have a vasectomized partner (confirmed sterile).

    Women with tubal ligation are required to use one non-hormonal contraceptive method.

    Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential.

  10. A positive pregnancy test or breast feeding at screening.
  11. Participation in an investigational drug trial within 90 days prior to the first intake of trial medication.
  12. Donation of blood or plasma within 60 days preceding the first trial-related blood drawing.
  13. Subjects with the following laboratory abnormalities at screening as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS grading table") and in accordance with the normal ranges of the trial clinical laboratory:

    • serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range [ULN]);
    • lipase or pancreatic amylase grade 1 or greater (≥ 1.1 x ULN);
    • hemoglobin grade 1 or greater (≤ 10.9 g/dL)
    • platelet count grade 1 or greater (≤ 124.999 x 109/L);
    • absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);
    • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN);
    • total bilirubin grade 1 or greater (≥ 1.1 x ULN),
    • any other laboratory abnormality of grade 2 or above
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00885495
IDC 40
No
Carl J. Fichtenbaum, MD, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Carl J Fichtenbaum, MD University of Cincinnati
University of Cincinnati
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP