HIV InfectionsPhase 4NCT00384904
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
A Phase 4 study testing Atazanavir/Ritonavir, Atazanavir/Ritonavir + Famotidine and Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine in people with HIV Infections, run by Bristol-Myers Squibb at 4 sites in 2 countries.
Trial summary
The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atazanavir/Ritonavir, Atazanavir/Ritonavir + Famotidine and Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2006to Dec 2007
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
- Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA <400 copies/mL and have CD4 count >200 cells/mm³
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Unc Center For Aids Research
Chapel Hill, North Carolina, 27599
Local Institution
Philadelphia, Pennsylvania, 19104
Garden State Infectious Disease Associates, Pa
Voorhees Township, New Jersey, 08043
United Kingdom1 site
Local Institution
London, Greater London, SW10 9TH
About this study
Official title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects
The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
- Conditions
- HIV Infections
- Being tested
- Atazanavir/Ritonavir, Atazanavir/Ritonavir + Famotidine, Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir/RitonavirDrug
Also called Reyataz
Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
Atazanavir/Ritonavir + FamotidineDrug
Also called Reyataz
Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
Atazanavir/Ritonavir + FamotidineDrug
Also called Reyataz
Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
Atazanavir/RitonavirDrug
Also called Reyataz
Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + FamotidineDrug
Also called Reyataz
Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + FamotidineDrug
Also called Reyataz
Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.
| Study group | Role | What they receive |
|---|---|---|
| A1 | No intervention | Not described Receives: Drug: Atazanavir/Ritonavir |
| A2 | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir + Famotidine |
| A3 | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir + Famotidine |
| B1 | No intervention | Not described Receives: Drug: Atazanavir/Ritonavir |
| B2 | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine |
| B3 | Experimental | Not described Receives: Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atazanavir plasma drug concentrations
Measured: on days 10, 11, 17, 18, 24 and 25
Secondary outcomes (6)
Ritonavir plasma drug concentrations
Measured: on days 10, 11, 17, 18, 24 and 25
Safety measures: Physical examinations
ECGs
Measured: entry and discharge
laboratory tests including, liver and renal function
Measured: entry, discharge and days 11, 18
CD4 count
Measured: discharge
HIV viral load
Measured: entry and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionDec 2007
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 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT00384904
- Sponsor's protocol ID
- AI424-328
- Status last verified
- Nov 2008
- First submitted
- 3 Oct 2006
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00384904
- Acronym / sponsor ID
- AI424-328
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Oct 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 Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 | No intervention | Drug: Atazanavir/Ritonavir |
| A2 | Experimental | Drug: Atazanavir/Ritonavir + Famotidine |
| A3 | Experimental | Drug: Atazanavir/Ritonavir + Famotidine |
| B1 | No intervention | Drug: Atazanavir/Ritonavir |
| B2 | Experimental | Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine |
| B3 | Experimental | Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
- Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA <400 copies/mL and have CD4 count >200 cells/mm³
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 |
|---|---|---|
| Atazanavir/RitonavirAlso: ReyatazCapsules/capsules, Oral, 300/100 mg, Once daily, 10 days. | Drug | A1 |
| Atazanavir/Ritonavir + FamotidineAlso: ReyatazCapsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days. | Drug | A2 |
| Atazanavir/Ritonavir + FamotidineAlso: ReyatazCapsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days. | Drug | A3 |
| Atazanavir/RitonavirAlso: ReyatazCapsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days. | Drug | B1 |
| Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + FamotidineAlso: ReyatazCapsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days. | Drug | B2 |
| Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + FamotidineAlso: ReyatazCapsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days. | Drug | B3 |
Primary outcome
Atazanavir plasma drug concentrations
Time frame: on days 10, 11, 17, 18, 24 and 25
6 secondary outcomes
Ritonavir plasma drug concentrations
Time frame: on days 10, 11, 17, 18, 24 and 25
Safety measures: Physical examinations
ECGs
Time frame: entry and discharge
laboratory tests including, liver and renal function
Time frame: entry, discharge and days 11, 18
CD4 count
Time frame: discharge
HIV viral load
Time frame: entry and discharge
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 5 Feb 2010.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir/Ritonavir, Atazanavir/Ritonavir + Famotidine and Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine in people with HIV Infections, run by Bristol-Myers Squibb at 4 sites in 2 countries.
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 2 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 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. 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?
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?
Atazanavir plasma drug concentrations (time frame: on days 10, 11, 17, 18, 24 and 25). 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 5 Feb 2010.