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Completed

NCT Number: NCT01388543

Genetics and HIV-1 Protease Inhibitors

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.

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Key information

Conditions

HIV

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atazanavir

Drug

Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days

Other names: Reyataz, Norvir

Primary outcomes

  1. Day 7 Atazanavir Oral Clearance

    Time frame: Day 7

    Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Genetic-determinants of Protease Inhibitor Pharmacology

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2011
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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