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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00002366

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Ritonavir	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.