Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002105
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Randomized Comparative Trial of DOX-SL Stealth Liposomal Doxorubicin Hydrochloride Versus Bleomycin and Vincristine in the Treatment of 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 Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
1996-01
Last Known Status:
None
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 moderate to severe AIDS-related Kaposis sarcoma KS by comparison with the established therapy BV bleomycinvincristine To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS
Detailed Description:
Patients are randomized to receive either DOX-SL or the BV combination Infusions are given on day 1 and every 3 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 who respond to therapy will be followed every 2 months for up to 1 year 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-30-11 | None | None | None |