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NCT00001993 · ClinicalTrials.gov registry record · Phase 2
Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3
A Phase 2 study of HIV Infections, sponsored by G D Searle.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 6
- Study locations
NCT00001993: Completed Phase 2 study of HIV Infections, sponsored by G D Searle.
NCT00001993 is a Phase 2 study of HIV Infections that has completed, run by G D Searle. The registered enrollment target is 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001993, a Phase 2 study of HIV Infections, has completed, sponsored by G D Searle.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3. The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Butyldeoxynojirimycin
Study Locations (6)
Florida
- Univ of Miami School of Medicine - Miami
Illinois
- Rush Presbyterian - Saint Luke's Med Ctr - Chicago
Indiana
- Infectious Diseases Research Clinic / Indiana Univ Hosp - Indianapolis
Ohio
- Ohio State Univ Hosp Clinic - Columbus
South Carolina
- Julio Arroyo - West Columbia
Washington
- Univ of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001993
The ClinicalTrials.gov registry entry for NCT00001993 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The listed sponsor is G D Searle, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00001993 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Florida, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT00001993 about?
NCT00001993 is a clinical study titled "Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3". The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3. The secondary objective is to determine the pharmacokinetics and bio...
What is the current status of trial NCT00001993?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants.
What conditions does trial NCT00001993 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001993?
The interventions under investigation include: Zidovudine (DRUG), Butyldeoxynojirimycin (DRUG).
Who is sponsoring clinical trial NCT00001993?
This trial is sponsored by G D Searle, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001993 being conducted?
This trial has 6 study locations across Florida, Illinois, Indiana, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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