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: December 11, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2011

Last Updated Date

December 11, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Drug levels and blood comparisons [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Compare atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Drug levels and blood comparisons [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Characterize the effect of ritonavir boosting on atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01388543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Genetics and HIV-1 Protease Inhibitors

Official Title ^ICMJE

Genetic-determinants of Protease Inhibitor Pharmacology

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

HIV

Intervention ^ICMJE

Drug: Atazanavir

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

Other Names:

Reyataz
Norvir

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, or inability to give informed consent.
A body mass index below 18.5 or above 34.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01388543

Other Study ID Numbers ^ICMJE

06-0428, R03AI068438, BMSV-338

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^ICMJE

Principal Investigator:

Peter L. Anderson, PharmD

University of Colorado Denver and Health Sciences Center

Information Provided By

University of Colorado, Denver

Verification Date

December 2012

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

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