The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma

HIV Infections Clinical Trial

Official title:

A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002366
• Other study ID #: 245C
• Secondary ID: M95-320
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.

• Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Concurrent Treatment:

Allowed:

Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Patients must have:

• Documentation of a positive ELISA test for HIV with a confirmatory test.

• Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.

• Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.

• Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Evidence of pulmonary Kaposi's sarcoma.

• Positive urine screen for recreational drugs.

• Current participation in another antiviral research study.

• Investigator anticipates poor patient compliance with the protocol.

• Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.

Concurrent Medication:

Excluded:

• Antiretroviral therapy.

• Protease inhibitor therapy.

• Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.

• Chemotherapy for Kaposi's sarcoma.

• Treatment with any medications that may interact with ritonavir.

Concurrent Treatment:

Excluded:

Radiotherapy for Kaposi's sarcoma.

Patients with any of the following prior conditions are excluded:

• History of psychiatric illness which is currently medically significant.

• History of pancreatitis.

Prior Medication:

Excluded:

• All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.

• Systemic chemotherapy of interferon within 30 days prior to study entry.

• Previous treatment with a protease inhibitor.

Risk Behavior:

Excluded:

Active substance abuse.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Ritonavir

Locations

Country	Name	City	State
Australia	Prince Henry's Hosp / Med Oncology	Sydney
Australia	Saint Vincent's Hosp Med Centre	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Carr A, Milliken S, Lewis C, Mitsuyasu R, Miles S, Newell M, Cooper DA. A pilot phase II safety and activity study of ritonavir in the treatment of HIV-associated cutaneous Kaposi's sarcoma. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:194 (abstract no 703)