Clinical Trial: 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)

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 Treatment or Intervention Phase
HIV Infections
 Drug: Zidovudine
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label

Further Study Details: 

Expected Total Enrollment:  18

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 above,  Genders Eligible for Study:  Both

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.

Location Information


California
      Palo Alto Veterans Affairs Health Care System, Palo Alto,  California,  94304,  United States

      Mount Zion Med Ctr / UCSF, San Francisco,  California,  94115,  United States

      Cedars Sinai Med Ctr, Los Angeles,  California,  90048,  United States

      AIDS Community Research Consortium, Redwood City,  California,  94063,  United States

Florida
      North Broward Hosp District, Fort Lauderdale,  Florida,  33316,  United States

      Goodgame Med Group, Maitland,  Florida,  32751,  United States

Illinois
      Univ of Illinois, Chicago,  Illinois,  60612,  United States

Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States

      Baylor College of Medicine / Houston Veterans Adm Med Ctr, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Cohn J,  Study Chair
Bilello J,  Study Chair

More Information

Click here for more information about Zidovudine

Study ID Numbers:  DATRI 012
Record last reviewed:  May 1996
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000818
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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