Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
Recruitment status was Active, not recruiting
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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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Procedure: antiviral therapy |
Phase 2 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART) |
- Efficacy [ Designated as safety issue: No ]
Estimated Enrollment: | 25 |
Study Start Date: | June 1998 |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130225152714im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Italy | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 |
Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
![](https://webarchive.library.unt.edu/web/20130225152714im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00003419 History of Changes |
Other Study ID Numbers: | CDR0000066438, ITA-GICAT-POS2, EU-97019 |
Study First Received: | November 1, 1999 |
Last Updated: | October 10, 2009 |
Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma |
Additional relevant MeSH terms:
Sarcoma, Kaposi Sarcoma Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Neoplasms, Vascular Tissue Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 21, 2013