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The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000999
  Purpose

To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity.

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Pharmacokinetics Study
Official Title:   A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS and Advanced ARC

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   500

Detailed Description:

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.

This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (> 72 hours) administration is not advised without dose supervision.

Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories:

  • AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol.
  • Patients who qualify for AZT under the labeling:
  • (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and < 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or > 15 lbs or > 10 percent of total body weight within the previous 3 months) and < 200 T4 cells and one or more of the following symptoms:
  • (1) fever > 100 degrees F without infectious cause of > 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare.

Note:

  • Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling.

Exclusion Criteria

Co-existing Condition:

  • Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded.

Concurrent Medication: Excluded:

  • Acetaminophen.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000999

Locations
United States, California
Univ of California / San Diego Treatment Ctr    
      San Diego, California, United States, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr    
      San Francisco, California, United States, 94115
San Francisco AIDS Clinic / San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
LaJolla Veterans Administration Med Ctr    
      LaJolla, California, United States, 92037
Stanford Univ School of Medicine    
      Stanford, California, United States, 94305
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
United States, Louisiana
Louisiana State Univ Med Ctr / Tulane Med School    
      New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine    
      New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Med Ctr    
      Boston, Massachusetts, United States, 02215
Beth Israel Deaconess - West Campus    
      Boston, Massachusetts, United States, 02215
United States, Minnesota
Univ of Minnesota    
      Minneapolis, Minnesota, United States, 55455
United States, New York
SUNY / State Univ of New York    
      Syracuse, New York, United States, 13210
Univ of Rochester Medical Center    
      Rochester, New York, United States, 14642
Mem Sloan - Kettering Cancer Ctr    
      New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
Jack Weiler Hosp / Bronx Municipal Hosp    
      Bronx, New York, United States, 10465
Bronx Municipal Hosp Ctr/Jacobi Med Ctr    
      Bronx, New York, United States, 10461
SUNY / Erie County Med Ctr at Buffalo    
      Buffalo, New York, United States, 14215
Beth Israel Med Ctr / Peter Krueger Clinic    
      New York, New York, United States, 10003
United States, North Carolina
Duke Univ Med Ctr    
      Durham, North Carolina, United States, 27710
United States, Pennsylvania
Univ of Pittsburgh Med School    
      Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Investigators
Study Chair:     Pettinelli C    
Study Chair:     Feinberg J    
  More Information


Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   ACTG 020
First Received:   November 2, 1999
Last Updated:   August 25, 2008
ClinicalTrials.gov Identifier:   NCT00000999
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Zidovudine  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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