Phase 4
Completed N=31
Genetics and HIV-1 Protease Inhibitors
Source: ClinicalTrials.gov NCT01388543 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Day 7 Atazanavir Oral Clearance — .25; .18 L/h/kg
◆ Published Evidence
Established
49citations · ~3 / year
Atazanavir pharmacokinetics in genetically determined CYP3A5 expressors versus non-expressors.
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.
Linked Publications (3)
-
Atazanavir pharmacokinetics in genetically determined CYP3A5 expressors versus non-expressors.
-
A population pharmacokinetic-pharmacogenetic analysis of atazanavir.
-
Atazanavir metabolism according to CYP3A5 status: an in vitro-in vivo assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day 7 Atazanavir Oral Clearance |
.25; .18 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01388543) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.