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NCT00000818 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.

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000818
Other study ID # DATRI 012
Secondary ID
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated July 28, 2008

Study information
Verified date May 1996
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zidovudine

Locations
Country Name City State
United States Univ of Illinois Chicago Illinois
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States North Broward Hosp District Fort Lauderdale Florida
United States Baylor College of Medicine / Houston Veterans Adm Med Ctr Houston Texas
United States Cedars Sinai Med Ctr Los Angeles California
United States Goodgame Med Group Maitland Florida
United States Palo Alto Veterans Affairs Health Care System Palo Alto California
United States AIDS Community Research Consortium Redwood City California
United States Mount Zion Med Ctr / UCSF San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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