The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Exclusion Criteria

• •Co-existing Condition:
• •Patients with any of the following symptoms and conditions are excluded:
• •Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.
• •Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
• •Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.
• •Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.
• •Patients with any of the following prior conditions are excluded:
• •A new AIDS-defining event diagnosed within 1 month prior to baseline.
• •Any patient who has previously been discontinued from zidovudine, lamivudine, and/or stavudine due to a drug-related toxicity.
• •Significant history of peripheral neuropathy.
• •1\. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
• •Saquinavir, ritonavir, nelfinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
• •1\. Prior use of adefovir dipivoxil.
• •Prior non-protease antiretroviral therapy (other than antiretroviral vaccines) for greater than 4 cumulative weeks.
• •Prior use of any antiretroviral protease inhibitor.
• •Immunizations within 30 days of baseline.
• •Antiretroviral vaccine therapy within 60 days of baseline.
• •Treatment in the 4 weeks prior to baseline, with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
• •Any other investigational drug within 30 days prior to baseline.
• •Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
• •Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.