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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Zidovudine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 009275800
    • San Juan Veterans Administration Med Ctr
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Univ of Arizona / Health Science Ctr
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ Med School
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian - Saint Luke's Med Ctr
    • Chicago, Illinois, United States, 60612
      • Cook County Hosp
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Univ of Missouri at Kansas City School of Medicine
  • New Jersey
    • Newark, New Jersey, United States, 071032842
      • North Jersey Community Research Initiative
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
  • New York
    • Manhasset, New York, United States, 11030
      • Northshore Hosp / Cornell Univ
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Univ of Pennsylvania / HIV Clinic
  • Texas
    • Galveston, Texas, United States, 77550
      • Univ TX Galveston Med Branch
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Glaxo Wellcome

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: February 1, 1992

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Zidovudine
• Other Study ID Numbers: 014L; 28