Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003419
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposis Sarcoma
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of HIV-Related Kaposis Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy HAART
Status:
UNKNOWN
Status Verified Date:
2001-11
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:
RATIONALE HIV virus is found in the lesions of most patients with Kaposis sarcoma and may have a role in causing Kaposis sarcoma Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposis sarcoma
PURPOSE This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposis sarcoma
PURPOSE This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Determine the efficacy of highly active antiretroviral therapy HAART in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposis sarcoma
OUTLINE Patients receive therapy consisting of nucleoside analogues RTI and protease inhibitors PI Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs Treatment continues for 12 weeks then progression is assessed
Patients with stable or regressing Kaposis sarcoma KS with a viral load of greater than 500 copies of RNAmL may continue with the therapy if the viral load has decreased by greater than 2 logs or may modify therapy if the viral load has decreased less than 2 logs Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy Treatment continues for at least 48 weeks
Patients are followed every 8 weeks until week 48
PROJECTED ACCRUAL This study will accrue a total of 14-25 patients
Determine the efficacy of highly active antiretroviral therapy HAART in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposis sarcoma
OUTLINE Patients receive therapy consisting of nucleoside analogues RTI and protease inhibitors PI Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs Treatment continues for 12 weeks then progression is assessed
Patients with stable or regressing Kaposis sarcoma KS with a viral load of greater than 500 copies of RNAmL may continue with the therapy if the viral load has decreased by greater than 2 logs or may modify therapy if the viral load has decreased less than 2 logs Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy Treatment continues for at least 48 weeks
Patients are followed every 8 weeks until week 48
PROJECTED ACCRUAL This study will accrue a total of 14-25 patients
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 |
|---|---|---|---|
| EU-97019 | None | None | None |
| ITA-GICAT-POS2 | None | None | None |