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NCT00000781 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 1,292
- Enrollment target
NCT00000781 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,292 participants.
The verdict
NCT00000781, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,292 participants
- Enrollment target
Study Summary
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Interventions
- DRUG Zidovudine
- DRUG Didanosine
- DRUG Nevirapine
- DRUG Zalcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,292 participants |
| Est. Completion | 1996-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000781
The ClinicalTrials.gov registry entry for NCT00000781 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00000781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000781 about?
NCT00000781 is a clinical study titled "A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)". To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in pati...
What is the current status of trial NCT00000781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,292 participants. Estimated completion is 1996-09.
What interventions are being tested in trial NCT00000781?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Nevirapine (DRUG), Zalcitabine (DRUG).
Who is sponsoring clinical trial NCT00000781?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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