A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma
- 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.
Localized radiotherapy will be allowed for lesions which will not be used as indicator or
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.
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.
- 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.
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.
- 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.
Active substance abuse.