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NCT00002105 · ClinicalTrials.gov registry record · Phase 3
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
A Phase 3 study of HIV Infections and Sarcoma, Kaposi, sponsored by Sequus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 4
- Study locations
NCT00002105: Completed Phase 3 study of HIV Infections and Sarcoma, Kaposi, sponsored by Sequus Pharmaceuticals.
NCT00002105 is a Phase 3 study of HIV Infections and Sarcoma, Kaposi that has completed, run by Sequus Pharmaceuticals. The registered enrollment target is 220 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (51% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002105, a Phase 3 study of HIV Infections and Sarcoma, Kaposi, has completed, sponsored by Sequus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 4
- Study locations
Study Summary
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
Conditions Studied
Interventions
- DRUG Doxorubicin hydrochloride (liposomal)
- DRUG Bleomycin sulfate
- DRUG Vincristine sulfate
Study Locations (4)
Massachusetts
- Beth Israel Hosp - Boston
New York
- Mount Sinai Med Ctr - New York
Texas
- Twelve Oaks Hosp - Houston
Washington
- Virginia Mason Research Center / Clinical Trial Unit - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Phase | Phase 3 |
What the finished NCT00002105 record still lists
NCT00002105 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Doxorubicin hydrochloride (liposomal) is the first listed.
NCT00002105 reports a single indexed study location in Massachusetts, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT00002105 about?
NCT00002105 is a clinical study titled "Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma". To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a popula...
What is the current status of trial NCT00002105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants.
What conditions does trial NCT00002105 study?
This clinical trial studies the following conditions: HIV Infections, Sarcoma, Kaposi.
What interventions are being tested in trial NCT00002105?
The interventions under investigation include: Doxorubicin hydrochloride (liposomal) (DRUG), Bleomycin sulfate (DRUG), Vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT00002105?
This trial is sponsored by Sequus Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002105 being conducted?
This trial has 4 study locations across Massachusetts, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00002105's enrollment target sits among peer trials
220 158th of 542 higher than 383 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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