The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients

Inclusion Criteria Concurrent Medication: Allowed: Topical and/or antifungal agents, except ketoconazole. Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated. Clinically indicated antibiotics, unless excluded. Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided. Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim). Didanosine (ddI). Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication. Patients must have: A working diagnosis of HIV infection. A CD4+ count between 200 and 500 cells/mm3. Signed, informed parental consent if patient is less than 18. NOTE: The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry. Concurrent Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors. Protease inhibitors except IDV. Rifabutin and rifampin. Ketoconazole. Terfenadine, astemizole, cisapride, triazolam and midazolam. Patients with any of the following prior conditions are excluded: History of prior saquinavir (SQV) therapy for more than 14 days. History of any prior protease inhibitor therapy other than SQV. History of serious opportunistic infection.