Inclusion Criteria
Concurrent Medication:
Allowed with caution and/or careful monitoring:
- Drugs which may interact at CYP3A4 (e.g., alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, simvastatin, and warfarin).
- Drugs that inhibit cytosolic alcohol dehydrogenase (e.g., ethanol, disulfiram, chlorzoxazone, chlorpromazine, isoniazid, and chloral hydrate).
- Drugs known to affect renal tubular secretion (e.g., probenecid or cimetidine), cause liver toxicity, or induce myelosuppression.
Patients must have:
- Documented and confirmed acute HIV-1 infection.
- No prior exposure to antiretroviral treatment.
- Ability to comply with the investigational nature of the study for a minimum of 48 weeks.
- Consent of parent or guardian if under the age of 18.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- A clinical diagnosis of AIDS, excluding CD4+ cell counts less than 200/mm3.
- A serious medical condition such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, compromises the safety of the patient.
- Institutionalized or mentally disabled.
- Inability to comply with the dosing schedule and protocol evaluations for reasons other than those specified.
Concurrent Medication:
Excluded:
- Concurrent therapy with rifampin, rifabutin, terfenadine, astemizole, ketoconazole, itraconazole, cisapride, triazolam, midazolam, quinidine, amiodarone, and/or ergotamine/dihydroergotamine-containing regimens.
- Foscarnet or therapy with other agents with documented in vitro or in vivo activity against HIV-1.
- Medications known to induce or inhibit hepatic cytochrome P450 enzyme systems.
- Vitamin E supplements.
Concurrent Treatment:
Excluded:
- Dependence on blood transfusions.
- Other investigational treatments.
Patients with the following prior conditions are excluded:
- A history of clinically relevant pancreatitis or hepatitis within 6 months of study entry.
- A history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
- An unexplained fever above 38.5 Celsius for more than 14 days within 30 days of study entry.
- A history of coagulopathy.
Prior Medication:
Excluded:
- Prior exposure to antiretroviral therapy.
- Therapy with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons, cytotoxic chemotherapeutic agents, or anti-oxidants within 30 days of study entry.
Prior Treatment:
Excluded:
- Radiation therapy within 30 days of study entry.
Risk Behavior:
Excluded:
Alcohol or illicit drug use which, in the opinion of the investigator, may interfere with ability to comply with the dosing schedule and protocol evaluations.
Purpose
