HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Brief summary
To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.
Interventions
DRUGZidovudine
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed