Genetics and HIV-1 Protease Inhibitors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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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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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CYP3A5 Expressors

A pre-screening genetic test determines CYP3A5 expressor status

Group Type ACTIVE_COMPARATOR

Atazanavir

Intervention Type DRUG

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

CYP3A5 Non-expressors

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

Group Type ACTIVE_COMPARATOR

Atazanavir

Intervention Type DRUG

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

Interventions

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Atazanavir

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

Intervention Type DRUG

Other Intervention Names

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Reyataz Norvir

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes