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.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000818
First received: November 2, 1999
Last updated: July 28, 2008
Last verified: May 1996
  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 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, United States, 94304
AIDS Community Research Consortium
Redwood City, California, United States, 94063
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00000818     History of Changes
Other Study ID Numbers: DATRI 012
Study First Received: November 2, 1999
Last Updated: July 28, 2008
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014