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NCT00300573 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs
A Phase 2 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT00300573 is a Phase 2 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 250 participants.
The verdict
NCT00300573, a Phase 2 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).
Interventions
- DRUG Dexelvucitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00300573
The ClinicalTrials.gov registry entry for NCT00300573 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dexelvucitabine is the first listed.
NCT00300573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00300573 about?
NCT00300573 is a clinical study titled "Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs". The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and N...
What is the current status of trial NCT00300573?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2006-04. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00300573?
The interventions under investigation include: Dexelvucitabine (DRUG).
Who is sponsoring clinical trial NCT00300573?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
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