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

Inclusion Criteria

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.