HIV InfectionsPhase 1NCT00362726
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
A Phase 1 study testing Rosiglitazone maleate, Atazanavir Sulphate and Atazanavir Sulphate + Rosiglitazone maleate in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Rosiglitazone maleate, Atazanavir Sulphate and Atazanavir Sulphate + Rosiglitazone maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
- Conditions
- HIV Infections
- Being tested
- Rosiglitazone maleate, Atazanavir Sulphate, Atazanavir Sulphate + Rosiglitazone maleate, Atazanavir Sulphate + Ritonavir, Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone maleateDrug
Tablets, Oral, RGZ 4 mg, once daily, 1 day.
Atazanavir SulphateDrug
Also called Reyataz
Capsules, Oral, ATV 400 mg, once daily, 5 days.
Atazanavir Sulphate + Rosiglitazone maleateDrug
Also called Reyataz
Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Atazanavir Sulphate + RitonavirDrug
Also called Reyataz
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Atazanavir Sulphate + Ritonavir + Rosiglitazone maleateDrug
Also called Reyataz
Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Rosiglitazone maleate |
| B | Active comparator | Not described Receives: Drug: Atazanavir Sulphate |
| C | Active comparator | Not described Receives: Drug: Atazanavir Sulphate + Rosiglitazone maleate |
| D | Active comparator | Not described Receives: Drug: Atazanavir Sulphate + Ritonavir |
| E | Active comparator | Not described Receives: Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
Secondary outcomes (2)
To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2006
- Study completionNov 2006
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.
- More trials run by Bristol-Myers SquibbThe 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 1
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362726
- Sponsor's protocol ID
- AI424-106
- Status last verified
- Jun 2008
- First submitted
- 9 Aug 2006
- Last updated
- 8 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00362726
- Acronym / sponsor ID
- AI424-106
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 10 Aug 2006 (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.
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Rosiglitazone maleate |
| B | Active comparator | Drug: Atazanavir Sulphate |
| C | Active comparator | Drug: Atazanavir Sulphate + Rosiglitazone maleate |
| D | Active comparator | Drug: Atazanavir Sulphate + Ritonavir |
| E | Active comparator | Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Rosiglitazone maleateTablets, Oral, RGZ 4 mg, once daily, 1 day. | Drug | A |
| Atazanavir SulphateAlso: ReyatazCapsules, Oral, ATV 400 mg, once daily, 5 days. | Drug | B |
| Atazanavir Sulphate + Rosiglitazone maleateAlso: ReyatazCapsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day. | Drug | C |
| Atazanavir Sulphate + RitonavirAlso: ReyatazCapsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days. | Drug | D |
| Atazanavir Sulphate + Ritonavir + Rosiglitazone maleateAlso: ReyatazCapsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day. | Drug | E |
Primary outcome
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
2 secondary outcomes
To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
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 8 Apr 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosiglitazone maleate, Atazanavir Sulphate and Atazanavir Sulphate + Rosiglitazone maleate in people with HIV Infections, run by Bristol-Myers Squibb 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 1 inclusion and 0 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 8 Apr 2011. 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 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?
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.. 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 8 Apr 2011.