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| 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 |
| 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. |
| Estimated 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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded during the first 8 weeks of study:
Prior Medication:
Excluded:
Contacts and 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 | |||||
| Study Chair: | Cohn J | |
| Study Chair: | Bilello J |
More Information
Click here for more information about Zidovudine 
  |
| 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 |
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