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.