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NCT00242879 · ClinicalTrials.gov registry record · Phase 2
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
A Phase 2 study, sponsored by ViiV Healthcare.
- Terminated
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT00242879 is a Phase 2 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 130 participants.
The verdict
NCT00242879, a Phase 2 study, was terminated before completion, sponsored by ViiV Healthcare.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.
Interventions
- DRUG Physician determined comparator PI + ritonavir
- DRUG GW640385 + ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00242879
The ClinicalTrials.gov registry entry for NCT00242879 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 130 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 2 interventions - of which Physician determined comparator PI + ritonavir is the first listed.
NCT00242879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00242879 about?
NCT00242879 is a clinical study titled "A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults". This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 day...
What is the current status of trial NCT00242879?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2005-08. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00242879?
The interventions under investigation include: Physician determined comparator PI + ritonavir (DRUG), GW640385 + ritonavir (DRUG).
Who is sponsoring clinical trial NCT00242879?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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