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NCT00098722 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 474
- Enrollment target
NCT00098722: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT00098722 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 474 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098722, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 474 participants
- Enrollment target
Study Summary
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 infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia 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.
Primary Outcome
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Interventions
- DRUG Maraviroc (UK-427,857)
- DRUG optimized background therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2004-12 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00098722 record still lists
NCT00098722 is an interventional study that assigns participants to a tested intervention. The registered 474 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher).
The record links to 0 conditions, and to 2 interventions - of which Maraviroc (UK-427,857) is the first listed.
NCT00098722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00098722 about?
NCT00098722 is a clinical study titled "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". 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 H...
What is the current status of trial NCT00098722?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 474 participants. The study started on 2004-12. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00098722?
The interventions under investigation include: Maraviroc (UK-427,857) (DRUG), optimized background therapy (DRUG).
Who is sponsoring clinical trial NCT00098722?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00098722's enrollment target sits among peer trials
474 77th of 2000 higher than 1,923 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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