Genetics and HIV-1 Protease Inhibitors

NCT01388543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-11-19

Study results available
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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.

Conditions

Interventions

DRUG

Atazanavir

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Peter L. Anderson, PharmD · University of Colorado Denver and Health Sciences Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388543 on ClinicalTrials.gov