Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC
2 other identifiers
interventional
N/A
2 countries
12
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.
Trial Health
Trial Health Score
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12 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- 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:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (12)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131, United States
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico