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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003419

Enrollment

Registered

2003-01-27

Start date

1998-06-30

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma

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.

Interventions

PROCEDUREantiviral therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Efficacy	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026