Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • - Prophylaxis or treatment for Pneumocystis carinii pneumonia (PCP) consisting of either trimethoprim / sulfamethoxazole, aerosolized pentamidine, pyrimethamine / sulfadoxine, or dapsone allowed at the discretion of the investigator.
• Patients with the following are excluded:
• • Any immediately life-threatening infection or medical condition present at the time of study entry.
• • Any active opportunistic or other infection requiring chronic therapy at the time of study entry. Patients with PCP may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have a fever \< 39 C for at least 48 hours, pO2 (on room air ) = or \> 60 mm, and an Arterial/alveolar gradient = or \< 30 mm.
• • Diagnosis of AIDS Dementia Complex.
• • Received more than 4 weeks of antiretroviral therapy or who previously discontinued antiretroviral therapy due to drug related toxicity.
• • Diseases and conditions listed in Exclusion Co-existing Conditions.
• Patients must have the following:
• • Seropositive for HIV infection documented by any federally licensed ELISA and confirmed by Western blot.
• • Advanced HIV disease or AIDS-related complex.
• • Ability to give informed consent.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • AIDS with malignant disease likely to require cytotoxic chemotherapy.
• • Diagnosis of AIDS Dementia Complex.
• • Impaired renal function ( Creatinine clearance \< 50 ml/min/1.73m2 or serum creatinine = or \> 2 mg/dl).
• • Impaired hepatic function ( ALT = or \> 5 x upper limit of normal).
• • Fever \> 39 C at entry.
• Concurrent Medication:
• Excluded:
• • Any other experimental therapy.
• • Drugs which cause significant bone marrow suppression.
• • Cytolytic chemotherapy.
• • Drugs which cause significant nephrotoxicity or hepatotoxicity.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy (with the exception of electron beam therapy to an area \< 100 cm2).
• Prior Medication:
• Excluded within 2 weeks of study entry:
• • - Any other experimental therapy. Drugs which cause significant bone marrow suppression. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity.
• Excluded within 4 weeks of entry:
• • - Immunomodulating agents, including pharmacological doses of steroids for more than 10 days (except for management of severe PCP in which case duration should not exceed 21 days). Interferon. Isoprinosine. IL-2.
• Excluded within 8 weeks of entry:
• • -
• Antiretroviral agents including:
• • - Ribavirin. Dideoxycytidine (ddC). Dideoxyadenosine (ddA). Didanosine (ddI). Foscarnet. Dextran Sulfate. AL-721. Retrovir (Zidovudine, AZT) for greater than 4 weeks or within 90 days of study entry, or patients who originally discontinued Retrovir due to drug-related toxicity. Drugs metabolized by hepatic glucuronidation may alter the metabolism of Retrovir and should not be used chronically.
• Prior Treatment:
• Excluded:
• • Radiation therapy (with the exception of electron beam therapy to an area \< 100 cm2) within 2 weeks of study entry.
• • Known active drug or alcohol abuse.