HIV-1 InfectionPhase 1NCT01000818
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
A Phase 1 study testing MK0518 (Raltegravir), famotidine and omeprazole in people with HIV-1 Infection and HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection, HIV Infections
- What is being tested?
- MK0518 (Raltegravir), famotidine and omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is Human immunodeficiency virus (HIV) positive
- Patient is taking an MK0518 (Raltegravir) containing regimen
- Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
- Patient who is of reproductive potential agrees to use an acceptable method of birth control
- Patients baseline health is stable
Who cannot join
- Patient has a history of stroke or chronic seizures.
- Patient has a history of gastric bypass surgery
- Patient is pregnant of breastfeeding
- Patient consumes excessive amounts of caffeinated beverages daily
- Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
About this study
Official title: An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
- Conditions
- HIV-1 Infection, HIV Infections
- Being tested
- MK0518 (Raltegravir), famotidine, omeprazole
- Keywords
- Treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0518 (Raltegravir)Drug
Also called Raltegravir
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
famotidineDrug
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
omeprazoleDrug
20 mg oral tablet of omeprazole, once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | MK0518 Receives: Drug: MK0518 (Raltegravir) |
| Period 2 | Experimental | famotidine + MK0518 Receives: Drug: MK0518 (Raltegravir); Drug: famotidine |
| Period 3 | Experimental | omeprazole + MK0518 Receives: Drug: MK0518 (Raltegravir); Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
Area Under the Plasma Concentration-Time Curve and peak concentration
Measured: 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2009
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.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000818
- Sponsor's protocol ID
- 0518-054
- Other IDs
- MK0518-054, 2009_681
- Status last verified
- Feb 2017
- First submitted
- 22 Oct 2009
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
- ClinicalTrials.gov ID
- NCT01000818
- Acronym / sponsor ID
- 0518-054
- Conditions
- HIV-1 Infection, HIV Infections
- Keywords
- Treatment experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 28 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: MK0518 (Raltegravir)MK0518 |
| Period 2 | Experimental | Drug: MK0518 (Raltegravir), Drug: famotidinefamotidine + MK0518 |
| Period 3 | Experimental | Drug: MK0518 (Raltegravir), Drug: omeprazoleomeprazole + MK0518 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is Human immunodeficiency virus (HIV) positive
- Patient is taking an MK0518 (Raltegravir) containing regimen
- Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
- Patient who is of reproductive potential agrees to use an acceptable method of birth control
- Patients baseline health is stable
Key exclusion criteria (5 listed)
- Patient has a history of stroke or chronic seizures.
- Patient has a history of gastric bypass surgery
- Patient is pregnant of breastfeeding
- Patient consumes excessive amounts of caffeinated beverages daily
- Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
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 |
|---|---|---|
| MK0518 (Raltegravir)Also: Raltegravir400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. | Drug | Period 1, Period 2, Period 3 |
| famotidineSingle 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518 | Drug | Period 2 |
| omeprazole20 mg oral tablet of omeprazole, once daily for 5 days | Drug | Period 3 |
Primary outcome
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
Time frame: 12 hours postdose
Area Under the Plasma Concentration-Time Curve and peak concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK0518 (Raltegravir), famotidine and omeprazole in people with HIV-1 Infection and HIV Infections, run by Merck Sharp & Dohme LLC.
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 5 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 21 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 28 May 2010). 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?
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir (time frame: 12 hours postdose). 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 21 Mar 2017.