Viewing Study NCT00002318



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00002318
Status: UNKNOWN
Last Update Posted: 2005-06-24
First Post: 1999-11-02

Brief Title: A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposis Sarcoma
Sponsor: Sequus Pharmaceuticals
Organization: NIH AIDS Clinical Trials Information Service

Study Overview

Official Title: Randomized Comparative Trial of DOX-SL Stealth Liposomal Doxorubicin Hydrochloride Versus Adriamycin Bleomycin and Vincristine ABV in the Treatment of Severe AIDS-Related Kaposis Sarcoma
Status: UNKNOWN
Status Verified Date: 1996-01
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To determine the efficacy of Stealth liposomal doxorubicin hydrochloride DOX-SL in the treatment of severe AIDS-related Kaposis sarcoma KS by comparison with the established therapy ABV Adriamycin doxorubicinbleomycinvincristine To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS
Detailed Description: Patients are randomized to receive either DOX-SL or the ABV combination Infusions are given on day 1 and every 2 weeks for a total of six cycles Kaposis sarcoma lesions are evaluated prior to every cycle at the end of the last treatment cycle and 4 weeks following the end of the last treatment Patients must agree to have one or more representative KS lesions biopsied

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
LTI-30-10 None None None