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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002020

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of Missouri at Kansas City School of Medicine — Kansas City, Missouri, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Univ of New Mexico Hlth Sciences Ctr / Dept of Med — Albuquerque, New Mexico, United States
• Northshore Hosp / Cornell Univ — Manhasset, New York, United States
• Univ of Pennsylvania / HIV Clinic — Philadelphia, Pennsylvania, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• San Juan Veterans Administration Med Ctr — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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