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Genetics and HIV-1 Protease Inhibitors

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01388543
First received: June 28, 2011
Last updated: May 1, 2017
Last verified: May 2017
June 28, 2011
May 1, 2017
September 2006
June 2008   (Final data collection date for primary outcome measure)
  • Drug level Clearance and blood comparisons [ Time Frame: Day 7 ]
    Compare atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
  • Drug level Clearance and blood comparisons [ Time Frame: Day 14 ]
    Characterize the effect of ritonavir boosting on atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
  • Drug levels and blood comparisons [ Time Frame: Day 7 ]
    Compare atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
  • Drug levels and blood comparisons [ Time Frame: Day 14 ]
    Characterize the effect of ritonavir boosting on atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Complete list of historical versions of study NCT01388543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetics and HIV-1 Protease Inhibitors
Genetic-determinants of Protease Inhibitor Pharmacology
This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
HIV
Drug: Atazanavir
Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
Other Names:
  • Reyataz
  • Norvir
  • Active Comparator: CYP3A5 Expressors
    A pre-screening genetic test determines CYP3A5 expressor status
    Intervention: Drug: Atazanavir
  • Active Comparator: CYP3A5 Non-expressors
    A pre-screening genetic test determines CYP3A5 non-expressor status
    Intervention: Drug: Atazanavir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 55 years
  • Negative HIV screening antibody test
  • CYP3A5 expressor status, race, and sex fit an enrollment opening.

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Medical history of

    • hepatitis B or C,
    • autoimmune disease,
    • active malignancy,
    • kidney disease including nephrolithiasis
  • Organ dysfunction manifested by

    • liver transaminases or
    • serum creatinine >1.25 times the upper limit of normal, or
    • any comprehensive metabolic test (except asymptomatic unconjugated hyperbilirubinemia), blood count, or lipid value > Grade I according to Division of AIDS (DAIDS) adverse drug event grading system (appendix).
  • Medical history of arrhythmias (including atrial fibrillation, atrioventricular block, and/or pacemaker)
  • Any QT interval abnormalities or other congenital arrhythmia syndromes on ECG or

    • Any ECG abnormality that in the opinion of the investigators would preclude entry into the study.
  • Medical history of any serious heart condition including:

    • congestive heart failure,
    • myopathies,
    • coronary artery disease, or
    • unexplained syncope.
  • Medical history of bleeding disorders (i.e., hemophilia)
  • Hyperlipidemia
  • Any prescription, herbal, recreational, or over-the-counter medication contraindicated with ritonavir or atazanavir including:

    • substrates/inhibitors/inducers of CYP3A/P-gp,
    • cardio-active medication, or
    • medications that alter the acid in the stomach. The study investigators will review each concurrent medication on a case-by-case basis.
  • Inability to refrain from grapefruit or grapefruit juice during the study.
  • Investigational drugs within the last 30 days.
  • Active alcohol / recreational drug abuse,
  • Inability to give informed consent.
  • A body mass index below 18.5 or above 34.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01388543
06-0428
R03AI068438 ( U.S. NIH Grant/Contract )
BMSV-338 ( Other Grant/Funding Number: Bristol-Myers Squibb )
Yes
Not Provided
Plan to Share IPD: No
Plan Description: No plan to share
University of Colorado, Denver
University of Colorado, Denver
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Peter L. Anderson, PharmD University of Colorado Denver and Health Sciences Center
University of Colorado, Denver
May 2017

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