Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003419

First received: November 1, 1999

Last updated: October 10, 2009

Last verified: November 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

October 10, 2009

Start Date ^ICMJE

June 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Efficacy [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003419 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma

Official Title ^ICMJE

Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)

Brief Summary

RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.

Detailed Description

OBJECTIVES:

Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's 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 Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL 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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Sarcoma

Intervention ^ICMJE

Procedure: antiviral therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Stage I-III (NYU) Kaposi's sarcoma that is slowly progressive
- Stable disease without progression in diameter of tumor or in number of lesions (less than 50% increase in 3 months)
- No progressive disease during or after treatment for Kaposi's sarcoma
Level of viral load detectable independently from CD4+ cells
No other active AIDS pathologies

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-3

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 1500/mm3
Hemoglobin greater than 8 mg/dL

Hepatic:

Bilirubin less than 2.5 times normal
AST and ALT less than 5 times normal
Alkaline phosphatase less than 2.5 times normal

Renal:

Creatinine less than 2.5 times normal

Other:

No prior malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer
No active cytomegalovirus, herpes simplex 1 or 2, or herpes zoster infection requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other

No prior antiretroviral therapy OR
No prior highly active antiretroviral therapy (HAART)
No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00003419

Other Study ID Numbers ^ICMJE

CDR0000066438, ITA-GICAT-POS2, EU-97019

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centro di Riferimento Oncologico - Aviano

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Umberto Tirelli, MD

Centro di Riferimento Oncologico - Aviano

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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