HIV InfectionsPhase 1NCT00730223
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
A Phase 1 study testing Nevirapine and Efavirenz in people with HIV Infections, run by Vanderbilt University.
Trial summary
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine and Efavirenz
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy African American men and women.
- 18-55 years of age.
- Willing and able to provide written informed consent.
Who cannot join
- Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
- Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
- Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal.
- Positive pregnancy test in women of childbearing potential.
About this study
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.
- Conditions
- HIV Infections
- Being tested
- Nevirapine and Efavirenz
- Keywords
- Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine and EfavirenzDrug
Also called Viramune, Sustiva
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of single dose nevirapine and single dose efavirenz
Measured: 5-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMar 2004
- Primary completionMar 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Vanderbilt University
- Investigators
- David W Haas, MD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730223
- Sponsor's protocol ID
- 040062
- Other IDs
- GM31304, CFAR Discovery Grant
- Status last verified
- Feb 2013
- First submitted
- 4 Aug 2008
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
- ClinicalTrials.gov ID
- NCT00730223
- Acronym / sponsor ID
- 040062
- Conditions
- HIV Infections
- Keywords
- Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy African American men and women.
- 18-55 years of age.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
- Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
- Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal.
- Positive pregnancy test in women of childbearing potential.
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 |
|---|---|---|
| Nevirapine and EfavirenzAlso: Viramune, Sustivasingle oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz | Drug | – |
Primary outcome
Pharmacokinetics of single dose nevirapine and single dose efavirenz
Time frame: 5-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
David W Haas, MD principal investigator
Associate Professor of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine and Efavirenz in people with HIV Infections, run by Vanderbilt University.
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 5 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics of single dose nevirapine and single dose efavirenz (time frame: 5-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.