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Sponsored by: |
Sequus Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002319 |
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
Condition | Intervention | Phase |
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Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma |
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within the past 4 weeks:
Prior Treatment:
Excluded within the past 3 weeks:
Study ID Numbers: | 134C, LTI-30-12 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002319 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sarcoma, Kaposi Liposomes Doxorubicin Acquired Immunodeficiency Syndrome Drug Carriers |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Doxorubicin Immunologic Deficiency Syndromes Kaposi Sarcoma Herpesviridae Infections Virus Diseases Anti-Bacterial Agents |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Infection Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases Sarcoma, Kaposi |
Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Doxorubicin Pharmacologic Actions Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Sarcoma DNA Virus Infections |