Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Public ClinicalTrials.gov record NCT00098306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
Study identification
- NCT ID
- NCT00098306
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 601 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2004
- Primary completion
- Mar 31, 2007
- Completion
- Mar 31, 2011
- Last update posted
- Apr 26, 2012
2004 – 2011
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Sacramento | California | 95825 | — |
| Pfizer Investigational Site | San Francisco | California | 94115 | — |
| Pfizer Investigational Site | San Francisco | California | 94118 | — |
| Pfizer Investigational Site | San Francisco | California | 94121 | — |
| Pfizer Investigational Site | Auroa | Colorado | 80045 | — |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | — |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20036 | — |
| Pfizer Investigational Site | Tampa | Florida | 33602 | — |
| Pfizer Investigational Site | Tampa | Florida | 33614 | — |
| Pfizer Investigational Site | Vero Beach | Florida | 32960 | — |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | — |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | — |
| Pfizer Investigational Site | Santa Fe | New Mexico | 87505 | — |
| Pfizer Investigational Site | New York | New York | 10003 | — |
| Pfizer Investigational Site | Rochester | New York | 14642 | — |
| Pfizer Investigational Site | The Bronx | New York | 10467 | — |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0405 | — |
| Pfizer Investigational Site | Portland | Oregon | 97219 | — |
| Pfizer Investigational Site | Austin | Texas | 78705 | — |
| Pfizer Investigational Site | Annandale | Virginia | 22003 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00098306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2012 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00098306 live on ClinicalTrials.gov.