A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Inclusion Criteria

Patients must have:

• CD4+ cell count >= 100 /mm3.
• Plasma HIV RNA >= 30,000 copies/ml.
• Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
• Parent or legal guardian to sign written, informed consent for patients under the age of 18.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

• Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
• For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
• Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
• Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.

Concurrent Medication:

Excluded:

• Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
• Patients receiving other investigational drugs.
• Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
• Treatment with immunomodulators.
• Patients on methadone.

Concurrent Treatment:

Excluded:

• Treatment with radiation therapy within the 24 weeks of the study. NOTE:
• Localized radiation therapy may be permitted following consultation with the sponsor.

Patients with any of the following prior conditions are excluded:

• Subjects with a history of lymphoma.
• Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

• Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
• Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
• Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.
• Investigational HIV vaccine within the past 3 months.
• Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.

Prior Treatment:

Excluded:

• Treatment with radiation therapy within 1 month of entry.

Risk Behavior:

Excluded:

Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.