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Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.

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: NCT00000818
  Purpose

PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T lymphocyte counts between 100 and 500 cells/mm3.

SECONDARY: To determine the extent to which apoptosis (programmed cell death) occurs in these patients.

In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons. Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.


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
Official Title:   Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.

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

Estimated Enrollment:   18

Detailed Description:

In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons. Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.

Patients receive AZT daily for 8 weeks and are followed in clinic at weeks 2, 4, 6, 8, 9, and 14 (or possibly via telephone call at week 14). Patients undergo a lymph node biopsy at day 0 and week 8.

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis against AIDS-related opportunistic infections.
  • Supportive therapies, such as medications for nausea, vomiting, anemia, and analgesia.

Patients must have:

  • HIV infection.
  • CD4 count 100 - 500 cells/mm3.
  • At least two palpable lymph nodes.
  • Plasma viremia.
  • No CURRENT AIDS-defining conditions.
  • No prior antiretroviral treatment.

Exclusion Criteria

Concurrent Medication:

Excluded during the first 8 weeks of study:

  • Other antiretroviral agents.
  • Steroids.
  • Interleukins.
  • Interferons.
  • Cytotoxic chemotherapy.

Prior Medication:

Excluded:

  • Prior antiretroviral therapy.
  • Prior cytotoxic chemotherapy.
  • Acute therapy for an infection or another medical illness within 14 days prior to study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000818

Locations
United States, California
Palo Alto Veterans Affairs Health Care System    
      Palo Alto, California, United States, 94304
Mount Zion Med Ctr / UCSF    
      San Francisco, California, United States, 94115
Cedars Sinai Med Ctr    
      Los Angeles, California, United States, 90048
AIDS Community Research Consortium    
      Redwood City, California, United States, 94063
United States, Florida
North Broward Hosp District    
      Fort Lauderdale, Florida, United States, 33316
Goodgame Med Group    
      Maitland, Florida, United States, 32751
United States, Illinois
Univ of Illinois    
      Chicago, Illinois, United States, 60612
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas    
      Dallas, Texas, United States, 75235
Baylor College of Medicine / Houston Veterans Adm Med Ctr    
      Houston, Texas, United States, 77030

Sponsors and Collaborators

Investigators
Study Chair:     Cohn J    
Study Chair:     Bilello J    
  More Information


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

Study ID Numbers:   DATRI 012
First Received:   November 2, 1999
Last Updated:   July 28, 2008
ClinicalTrials.gov Identifier:   NCT00000818
Health Authority:   United States: Federal Government

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

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
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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