Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT00098293 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 916 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00098293 record still lists
NCT00098293 is an interventional study that assigns participants to a tested intervention. The registered 916 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 3 interventions - of which Maraviroc + Zidovudine/Lamivudine is the first listed.
NCT00098293 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00098293's enrollment target sits among peer trials
916 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05739955 · 918 participants · NA
Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms
- NCT06131840 · 914 participants · Phase 1
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
- NCT04589845 · 920 participants · Phase 2
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- NCT06109870 · 920 participants · NA
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia