HIV InfectionsPhase 1NCT00357240
Drug Interaction Study With Proton Pump Inhibitor
A Phase 1 study testing Atazanavir, Atazanavir/Ritonavir and Atazanavir/Ritonavir+Omeprazole 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 omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole 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?
- Atazanavir, Atazanavir/Ritonavir and Atazanavir/Ritonavir+Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 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 of 18 to 50 years old with 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: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects
The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Atazanavir/Ritonavir, Atazanavir/Ritonavir+Omeprazole
- Keywords
- Protease inhibitor
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called Reyataz
Capsules, Oral, 400 mg, once daily, 6 days.
Atazanavir/RitonavirDrug
Also called Reyataz
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Atazanavir/Ritonavir+OmeprazoleDrug
Also called Reyataz
Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
Atazanavir/Ritonavir+OmeprazoleDrug
Also called Reyataz
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
AtazanavirDrug
Also called Reyataz
Capsules, Oral, 400 mg, once daily, 6 days.
Atazanavir/RitonavirDrug
Also called Reyataz
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Atazanavir/Ritonavir+OmeprazoleDrug
Also called Reyataz
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
Atazanavir/Ritonavir+OmeprazoleDrug
Also called Reyataz
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Atazanavir |
| A2 | Active comparator | Not described Receives: Drug: Atazanavir/Ritonavir |
| A3 I | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir+Omeprazole |
| A3 II | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir+Omeprazole |
| B1 | Active comparator | Not described Receives: Drug: Atazanavir |
| B2 | Active comparator | Not described Receives: Drug: Atazanavir/Ritonavir |
| B3 I | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir+Omeprazole |
| B3 II | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir+Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Secondary outcomes (1)
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2006
- Study completionAug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT00357240
- Sponsor's protocol ID
- AI424-288
- Status last verified
- Jun 2008
- First submitted
- 25 Jul 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
- Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00357240
- Acronym / sponsor ID
- AI424-288
- Conditions
- HIV Infections
- Keywords
- Protease inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Jul 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 omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Atazanavir |
| A2 | Active comparator | Drug: Atazanavir/Ritonavir |
| A3 I | Experimental | Drug: Atazanavir/Ritonavir+Omeprazole |
| A3 II | Experimental | Drug: Atazanavir/Ritonavir+Omeprazole |
| B1 | Active comparator | Drug: Atazanavir |
| B2 | Active comparator | Drug: Atazanavir/Ritonavir |
| B3 I | Experimental | Drug: Atazanavir/Ritonavir+Omeprazole |
| B3 II | Experimental | Drug: Atazanavir/Ritonavir+Omeprazole |
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 of 18 to 50 years old with 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 |
|---|---|---|
| AtazanavirAlso: ReyatazCapsules, Oral, 400 mg, once daily, 6 days. | Drug | A1 |
| Atazanavir/RitonavirAlso: ReyatazCapsules/capsules, Oral, 300/100 mg, once daily, 10 days. | Drug | A2 |
| Atazanavir/Ritonavir+OmeprazoleAlso: ReyatazCapsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. | Drug | A3 I |
| Atazanavir/Ritonavir+OmeprazoleAlso: ReyatazCapsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. | Drug | A3 II |
| AtazanavirAlso: ReyatazCapsules, Oral, 400 mg, once daily, 6 days. | Drug | B1 |
| Atazanavir/RitonavirAlso: ReyatazCapsules/capsules, Oral, 300/100 mg, once daily, 10 days. | Drug | B2 |
| Atazanavir/Ritonavir+OmeprazoleAlso: ReyatazCapsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days. | Drug | B3 I |
| Atazanavir/Ritonavir+OmeprazoleAlso: ReyatazCapsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days. | Drug | B3 II |
Primary outcome
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
1 secondary outcome
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
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 Atazanavir, Atazanavir/Ritonavir and Atazanavir/Ritonavir+Omeprazole 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?
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, 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.