A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir

Inclusion Criteria

• •Concurrent Medication:
• •Required:
• •Chemoprophylaxis for Pneumocystis carinii pneumonia (for patients with a CD4+ cell count less than or equal to 200 cells/mm3.
• •Allowed:
• •Topical and/or oral antifungal agents.
• •Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections.
• •Antibiotics.
• •Systemic corticosteroid use for 21 days or less.
• •Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
• •Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of contraception), megestrol acetate, and testosterone.
• •Alternative therapies such as vitamins, acupuncture, and visualization techniques.
• •\[AS PER AMENDMENT 2/27/98:
• •Current use of triple therapy with amprenavir/3TC/ZDV (or d4T) for Arm A patients.
• •Current use of quadruple therapy with IDV/NVP/3TC/d4T for Arm B patients.\]
• •Patients must have:
• •HIV-positive status.
• •Successful response to treatment in ACTG 347 as measured by HIV RNA less than 500 copies/ml (Arm A) OR unsuccessful response to treatment in ACTG 347 or another regimen containing amprenavir OR an increase in plasma HIV RNA above the nadir value to greater than 5,000 copies/ml or by at least one log10 at any time (Arm B) OR intolerance to a regimen containing amprenavir.
• •Consent for patients less than 18 years of age.
• •\[AS PER AMENDMENT 2/27/98:
• •Arm A patients must have:
• •HIV RNA less than 500 copies/ml on at least one occasion within 60 days of entry while previously enrolled in ACTG 347 and in one of the following categories: currently receiving amprenavir/3TC/ZDV (or d4T) or randomized to monotherapy arm of ACTG 347 and received open-label amprenavir/3TC/ZDV (or d4T).
• •Arm B patients must have:
• •Failed prior amprenavir therapy, whether on ACTG 347 or not, i.e., HIV RNA greater than or equal to 500 copies/ml after at least 16 weeks of amprenavir and confirmed within 1-6 weeks OR treatment failure that mandated early permanent discontinuation of randomized ACTG 347 study drugs and defined as HIV RNA of at least one log 10 above the nadir (to at least 5,000 copies/ml) or HIV RNA level above the baseline value before 16 weeks of amprenavir and confirmed within 1-6 weeks.
• •Initially randomized to triple therapy arm of ACTG 347 with two plasma HIV-1 RNA values of at least 500 copies/ml taken within 60 days prior to study entry and at least 1-6 weeks apart or initially receive open-label amprenavir/3TC/ZDV (or d4T) and with two HIV RNA levels of at least 500 copies/ml, regardless of duration of treatment with amprenavir/3TC/ZDV (or d4T).
• •Documented intolerance to any of the reverse transcriptase inhibitors or attempted nevirapine therapy allowed. Arm C patients must have:
• •Previously enrolled on ACTG 347 and elected to receive a treatment regimen other than amprenavir/3TC/ZDV (or d4T) or IDV/NVP/3TC/d4T.\]
• •Prior Medication: Required:
• •Amprenavir therapy \[AS PER AMENDMENT 2/27/98:
• •amprenavir therapy (Arm A and B patients only)\].