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NCT00135369 · ClinicalTrials.gov registry record · Phase 3
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00135369 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 300 participants.
The verdict
NCT00135369, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.
Interventions
- DRUG stavudine extended-release, lamivudine, efavirenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2002-09 |
| Est. Completion | 2005-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135369
The ClinicalTrials.gov registry entry for NCT00135369 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which stavudine extended-release, lamivudine, efavirenz is the first listed.
NCT00135369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00135369 about?
NCT00135369 is a clinical study titled "Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen". The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of ...
What is the current status of trial NCT00135369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2002-09. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00135369?
The interventions under investigation include: stavudine extended-release, lamivudine, efavirenz (DRUG).
Who is sponsoring clinical trial NCT00135369?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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