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Home > "T" Clinical Trials Conditions > Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC  Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
United States
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
Cook County Hosp
Chicago, Illinois, 60612
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
Additional Information:
Study ID Numbers: 014L; 28
Study Start Date:
Record last reviewed: February 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002020
Other Hiv Infections Studies:
1. Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
2. HIV Prevention Preparedness Study
3. Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
4. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
5. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
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Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
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