Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

Inclusion Criteria

Concurrent Medication:

Recommended:

• PCP prophylaxis in patients with CD4 count <= 200 cells/mm3.

Allowed:

• Chemophylaxis against Mycobacterium tuberculosis.
• Acyclovir.
• Vaccination with pneumococcal vaccine polyvalent.
• Haemophilus B Conjugate vaccine.
• Chemoprophylaxis for MAC and Toxoplasma gondii.
• Antibiotics.
• Recombinant erythropoietin ( EPO ) and G-CSF.
• Systemic corticosteroids for < 21 days.
• Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives.
• Vitamins and herbal therapies.

Concurrent Treatment:

Allowed:

• Limited local radiation therapy to skin.
• Blood transfusions if 3 units or less per 21-day period.
• Acupuncture.
• Visualization techniques.

Patients must have:

• Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval.
• Not reached an ACTG 175 endpoint prior to May 1, 1995.
• Consent of parent or guardian if less than 18 years old.

PER AMENDMENT 8/27/96:

• Patients must be on study/on treatment at the time the protocol study treatment is extended.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Grade 2 or worse peripheral neuropathy.
• Malignancy requiring systemic therapy.

Concurrent Medication:

Excluded:

• Anti-HIV drugs other than study drugs.
• Biologic response modifiers.
• Systemic cytotoxic chemotherapy.
• Any drug known to affect glucuronidation and/or clearance of AZT.

Concurrent Treatment:

Excluded:

• Radiation therapy other than limited local therapy to skin.

Patients with the following prior condition are excluded:

• History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

• Prior 3TC.
• Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry.

Current ethanol abuse.