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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

antiviral therapy

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro di Riferimento Oncologico - Aviano

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT00003419

First Posted

November 1, 1999

Last Updated

September 19, 2013

Sponsor

Centro di Riferimento Oncologico - Aviano

1. Study Identification

Unique Protocol Identification Number

NCT00003419

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2001

Overall Recruitment Status

Unknown status

Study Start Date

June 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centro di Riferimento Oncologico - Aviano

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

AIDS-related Kaposi sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

antiviral therapy

Primary Outcome Measure Information:

Title

Efficacy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umberto Tirelli, MD

Organizational Affiliation

Centro di Riferimento Oncologico - Aviano

Official's Role

Study Chair

Facility Information:

Facility Name

Centro di Riferimento Oncologico - Aviano

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Sarcoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial