HIVPhase 4NCT01388543
Genetics and HIV-1 Protease Inhibitors
A Phase 4 study testing Atazanavir in people with HIV, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Atazanavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55 years
- Negative HIV screening antibody test
- CYP3A5 expressor status, race, and sex fit an enrollment opening.
Who cannot join
- Pregnant or breast-feeding
- Medical history of
- hepatitis B or C,
- autoimmune disease,
- active malignancy,
- kidney disease including nephrolithiasis
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
Official title: Genetic-determinants of Protease Inhibitor Pharmacology
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
- HIV
- Being tested
- Atazanavir
- Keywords
- Pharmacokinetics, Clinical Pharmacology, Pharmacogenomics, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called Reyataz, Norvir
Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
| Study group | Role | What they receive |
|---|---|---|
| CYP3A5 Expressors | Active comparator | A pre-screening genetic test determines CYP3A5 expressor status Receives: Drug: Atazanavir |
| CYP3A5 Non-expressors | Active comparator | A pre-screening genetic test determines CYP3A5 non-expressor status Receives: Drug: Atazanavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 7 Atazanavir Oral Clearance
Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter L. Anderson, PharmD, Principal investigator, University of Colorado Denver and Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388543
- Sponsor's protocol ID
- 06-0428
- Other IDs
- R03AI068438, BMSV-338
- Status last verified
- Oct 2019
- First submitted
- 28 Jun 2011
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share
Publications
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.
PubMed 19710077Wempe 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.
PubMed 21148251Kile 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.
PubMed 22394315
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic-determinants of Protease Inhibitor Pharmacology
- ClinicalTrials.gov ID
- NCT01388543
- Acronym / sponsor ID
- 06-0428
- Conditions
- HIV
- Keywords
- Pharmacokinetics, Clinical Pharmacology, Pharmacogenomics, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP3A5 Expressors | Active comparator | Drug: AtazanavirA pre-screening genetic test determines CYP3A5 expressor status |
| CYP3A5 Non-expressors | Active comparator | Drug: AtazanavirA pre-screening genetic test determines CYP3A5 non-expressor status |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 55 years
- Negative HIV screening antibody test
- CYP3A5 expressor status, race, and sex fit an enrollment opening.
Key exclusion criteria (29 listed)
- Pregnant or breast-feeding
- Medical history of
- Organ dysfunction manifested by
- Medical history of arrhythmias (including atrial fibrillation, atrioventricular block, and/or pacemaker)
- Any QT interval abnormalities or other congenital arrhythmia syndromes on ECG or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtazanavirAlso: Reyataz, NorvirAtazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days | Drug | CYP3A5 Expressors, CYP3A5 Non-expressors |
Primary outcome
Day 7 Atazanavir Oral Clearance
Time frame: Day 7
Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19710077Anderson 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.
- Results publication: PubMed 21148251Wempe 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.
- Results publication: PubMed 22394315Kile 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.
- Individual participant dataSharing planned: No. No plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L. Anderson, PharmD principal investigator
University of Colorado Denver and Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir in people with HIV, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 7 Atazanavir Oral Clearance (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.