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

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.