Inclusion Criteria

Concurrent Medication:

Required:

• Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 count of 200 cells/mm3 or less.

Allowed:

• Topical and oral antifungal except for oral ketoconazole.
• Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated.
• All antibiotics as clinically indicated.
• Systemic corticosteroid use for no more than 21 days for acute problems as medically indicated. Note: Steroid use for more than 21 days is considered on a case-by-case basis.
• Recombinant erythropoietin (rEPO) and granulocyte colony-stimulating factor (G-CSF) as medically indicated.
• Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate, testosterone, or any other medications as medically indicated.

[AS PER AMENDMENT 4/25/00:

Allowed with caution:

• Pentamidine, allopurinol, hydroxyurea. Use of these medications may increase exposure to ddI.]

Concurrent Treatment:

Allowed:

• Dependency of less than 3 units of blood per 21-day period.
• Alternative therapies such as acupuncture and visualization techniques.

Patients must have:

• HIV infection documented by a licensed ELISA and confirmed by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or second antibody test positive by a method other than ELISA. Repeat HIV-antibody testing is not required for enrollment in this trial (implicit in patients having been enrolled in ACTG 302/303).
• Signed, informed consent from parent or legal guardian for patients under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Inability to tolerate ddI at 200-400 mg/day, 3TC at 300 mg/day, or d4T at 60-80 mg/day, with intolerance defined as recurrent toxicities requiring dose interruptions and reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).
• Grade 2 or higher peripheral neuropathy.
• Malignancy requiring systemic therapy.
• Co-enrollment in other antiretroviral protocols; co-enrollment in other ACTG protocols is encouraged, particularly those involving prophylaxis for opportunistic infections.

Concurrent Medication:

Excluded:

• All antiretroviral therapies other than study medications.
• Investigational drugs and vaccines without specific approval from the Protocol Chair/Vice Chairs.
• Systemic cytotoxic chemotherapy.
• Interferon, interleukins, GM-CSF, and HIV-1 vaccines.
• Rifabutin and rifampin.
• Ketoconazole, astemizole, cisapride, midazolam, terfenadine, and triazolam.
• Acute therapy for an infection or other medical illness.
• Herbal medications.
• Vitamins. [10. AS PER AMENDMENT 3/5/98:
• Ergot alkaloids or drugs containing derivatives or ergot alkaloids.]

Patients with the following prior conditions are excluded:

• History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

• PIs.
• NNRTIs.
• Acute therapy for an infection or other medical illness within 14 days prior to the time of study entry.
• Chronic long-term steroid use is not permitted unless it is within physiologic replacement levels; protocol chair/vice chairs must be contacted in these instances.

Risk Behavior:

Excluded:

• Current ethanol abuse by personal history or a report from a primary physician.