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COMPLETED 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

NCT00002105 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 220 participants
Phase Phase 3

Sponsor

Sequus Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00002105

The ClinicalTrials.gov registry entry for NCT00002105 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sequus Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00002105 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00002105?

The interventions under investigation include: Doxorubicin hydrochloride (liposomal) (DRUG), Bleomycin sulfate (DRUG), Vincristine sulfate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00002105?

This trial is sponsored by Sequus Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial