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NCT00098293 · ClinicalTrials.gov registry record · Phase 3
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 916
- Enrollment target
NCT00098293 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 916 participants.
The verdict
NCT00098293, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 916 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 goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiog
Interventions
- DRUG Maraviroc + Zidovudine/Lamivudine
- DRUG Efavirenz + Zidovudine/Lamivudine
- DRUG Maraviroc (UK-427,857) + Zidovudine/Lamivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 916 participants |
| Start Date | 2004-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098293
The ClinicalTrials.gov registry entry for NCT00098293 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 916 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Maraviroc + Zidovudine/Lamivudine is the first listed.
NCT00098293 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00098293 about?
NCT00098293 is a clinical study titled "Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine". 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 NCT00098293?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 916 participants. The study started on 2004-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00098293?
The interventions under investigation include: Maraviroc + Zidovudine/Lamivudine (DRUG), Efavirenz + Zidovudine/Lamivudine (DRUG), Maraviroc (UK-427,857) + Zidovudine/Lamivudine (DRUG).
Who is sponsoring clinical trial NCT00098293?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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