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NCT00002199 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
A Phase 3 study, sponsored by Glaxo Wellcome.
- Completed
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
NCT00002199 is a Phase 3 study that has completed, run by Glaxo Wellcome. The registered enrollment target is 550 participants.
The verdict
NCT00002199, a Phase 3 study, has completed, sponsored by Glaxo Wellcome.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
Study Summary
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.
Interventions
- DRUG Indinavir sulfate
- DRUG Lamivudine/Zidovudine
- DRUG Abacavir sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002199
The ClinicalTrials.gov registry entry for NCT00002199 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glaxo Wellcome, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Indinavir sulfate is the first listed.
NCT00002199 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002199 about?
NCT00002199 is a clinical study titled "A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.". To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defin...
What is the current status of trial NCT00002199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants.
What interventions are being tested in trial NCT00002199?
The interventions under investigation include: Indinavir sulfate (DRUG), Lamivudine/Zidovudine (DRUG), Abacavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00002199?
This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.
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