NCT01388543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

June 28, 2011

Results QC Date

October 11, 2019

Last Update Submit

October 31, 2019

Conditions

HIV

Keywords

PharmacokineticsClinical PharmacologyPharmacogenomicsHIV

Outcome Measures

Primary Outcomes (1)

  • Day 7 Atazanavir Oral Clearance

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

    Day 7

Study Arms (2)

CYP3A5 Expressors

ACTIVE COMPARATOR

A pre-screening genetic test determines CYP3A5 expressor status

Drug: Atazanavir

CYP3A5 Non-expressors

ACTIVE COMPARATOR

A pre-screening genetic test determines CYP3A5 non-expressor status

Drug: Atazanavir

Interventions

AtazanavirDRUG

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

Also known as: Reyataz, Norvir
CYP3A5 ExpressorsCYP3A5 Non-expressors

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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,
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Anderson PL, Aquilante CL, Gardner EM, Predhomme J, McDaneld P, Bushman LR, Zheng JH, Ray M, MaWhinney S. Atazanavir pharmacokinetics in genetically determined CYP3A5 expressors versus non-expressors. J Antimicrob Chemother. 2009 Nov;64(5):1071-9. doi: 10.1093/jac/dkp317. Epub 2009 Aug 26.

    PMID: 19710077RESULT

  • Wempe MF, Anderson PL. Atazanavir metabolism according to CYP3A5 status: an in vitro-in vivo assessment. Drug Metab Dispos. 2011 Mar;39(3):522-7. doi: 10.1124/dmd.110.036178. Epub 2010 Dec 9.

    PMID: 21148251RESULT

  • Kile DA, MaWhinney S, Aquilante CL, Rower JE, Castillo-Mancilla JR, Anderson PL. A population pharmacokinetic-pharmacogenetic analysis of atazanavir. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1227-34. doi: 10.1089/aid.2011.0378. Epub 2012 Apr 20.

    PMID: 22394315RESULT

MeSH Terms

Interventions

Atazanavir SulfateRitonavir

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Results Point of Contact

Title
Dr. Peter Anderson
Organization
University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences
peter.anderson@cuanschutz.edu
3037246128

Study Officials

  • Peter L. Anderson, PharmD

    University of Colorado Denver and Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 6, 2011

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 19, 2019

Results First Posted

November 19, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations

US(1)