HIVPhase 2NCT00634959
Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
A Phase 2 study testing Maraviroc (UK-427,857) in people with HIV, run by ViiV Healthcare at 7 sites in 3 countries.
Trial summary
To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV
- What is being tested?
- Maraviroc (UK-427,857)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2003to Dec 2003
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Asymptomatic HIV-1 infected male and female patients
- Weight between 50 and 100kg and within the permitted range for their height
- Patients with virus that targets CCR5 receptor
Who cannot join
- Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
- Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
- Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
- Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany3 sites
Pfizer Investigational Site
Cologne, 50931
Pfizer Investigational Site
Frankfurt, 60596
Pfizer Investigational Site
Hamburg, 20099
United States2 sites
Pfizer Investigational Site
Birmingham, Alabama, 35294-2050
Pfizer Investigational Site
Boston, Massachusetts, 02215
United Kingdom2 sites
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
London, SW10 9NH
About this study
Official title: An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)
To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)
- Conditions
- HIV
- Being tested
- Maraviroc (UK-427,857), Placebo
- Keywords
- HIV Infections, Treatment Naïve
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc (UK-427,857)Drug
Also called Celsentri, Selzentry
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Maraviroc (UK-427,857)Drug
Also called Celsentri, Selzentry
100 mg oral tablet once daily while fasted on Days 1-10
Maraviroc (UK-427,857)Drug
Also called Celsentri, Selzentry
300 mg oral tablet once daily while fasted on Days 1-10
Maraviroc (UK-427,857)Drug
Also called Celsentri, Selzentry
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
PlaceboOther
Matching placebo oral tablet on Days 1-10 (fed and fasted)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Maraviroc (UK-427,857) |
| 2 | Experimental | Not described Receives: Drug: Maraviroc (UK-427,857) |
| 3 | Experimental | Not described Receives: Drug: Maraviroc (UK-427,857) |
| 4 | Experimental | Not described Receives: Drug: Maraviroc (UK-427,857) |
| 5 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in viral load
Measured: Day 11
UK-427,857 pharmacokinetics
Measured: Days 1-11
Secondary outcomes (11)
Physical examination
Measured: Days 1, 11, 40
12-lead ECG
Measured: Days 1-11 and Day 40
Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)
Measured: Days 1-11
Time course of viral load from baseline to follow-up
Measured: Days 1-13 and Days 15, 19, 22, 25, 40
CCR5 receptor saturation
Measured: Days 1, 5, 10, 11, 13, 15, 19, 40
Adverse events
Measured: Days 1-40
Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)
Measured: Days 1-11
Laboratory safety
Measured: Days 1, 3, 7, 11, 15, 40
Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)
Measured: Days 1-11
Supine/standing blood pressure and pulse rate
Measured: Days 1-11 and Day 40
Time to rebound of viral load
Measured: Days 1-13 and Days 15, 19, 22, 25, 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJul 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634959
- Sponsor's protocol ID
- A4001015
- Status last verified
- Nov 2010
- First submitted
- 5 Mar 2008
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)
- ClinicalTrials.gov ID
- NCT00634959
- Acronym / sponsor ID
- A4001015
- Conditions
- HIV
- Keywords
- HIV Infections, Treatment Naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2003
- Study completion
- Dec 2003 (actual)
- First posted
- 13 Mar 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 investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Maraviroc (UK-427,857) |
| 2 | Experimental | Drug: Maraviroc (UK-427,857) |
| 3 | Experimental | Drug: Maraviroc (UK-427,857) |
| 4 | Experimental | Drug: Maraviroc (UK-427,857) |
| 5 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Asymptomatic HIV-1 infected male and female patients
- Weight between 50 and 100kg and within the permitted range for their height
- Patients with virus that targets CCR5 receptor
Key exclusion criteria (4 listed)
- Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
- Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
- Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
- Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
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 |
|---|---|---|
| Maraviroc (UK-427,857)Also: Celsentri, Selzentry150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only) | Drug | 1 |
| Maraviroc (UK-427,857)Also: Celsentri, Selzentry100 mg oral tablet once daily while fasted on Days 1-10 | Drug | 2 |
| Maraviroc (UK-427,857)Also: Celsentri, Selzentry300 mg oral tablet once daily while fasted on Days 1-10 | Drug | 3 |
| Maraviroc (UK-427,857)Also: Celsentri, Selzentry150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only) | Drug | 4 |
| PlaceboMatching placebo oral tablet on Days 1-10 (fed and fasted) | Other | 5 |
Primary outcome
Change from baseline in viral load
Time frame: Day 11
UK-427,857 pharmacokinetics
Time frame: Days 1-11
11 secondary outcomes
Physical examination
Time frame: Days 1, 11, 40
12-lead ECG
Time frame: Days 1-11 and Day 40
Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)
Time frame: Days 1-11
Time course of viral load from baseline to follow-up
Time frame: Days 1-13 and Days 15, 19, 22, 25, 40
CCR5 receptor saturation
Time frame: Days 1, 5, 10, 11, 13, 15, 19, 40
Adverse events
Time frame: Days 1-40
Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)
Time frame: Days 1-11
Laboratory safety
Time frame: Days 1, 3, 7, 11, 15, 40
Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)
Time frame: Days 1-11
Supine/standing blood pressure and pulse rate
Time frame: Days 1-11 and Day 40
Time to rebound of viral load
Time frame: Days 1-13 and Days 15, 19, 22, 25, 40
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 10 Nov 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maraviroc (UK-427,857) in people with HIV, run by ViiV Healthcare at 7 sites in 3 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 3 inclusion and 4 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in viral load (time frame: Day 11). The study lists 2 primary outcomes in all. 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 10 Nov 2010.