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.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000818
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 18
- Last updated by the study team
- 2008-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cedars Sinai Med Ctr — Los Angeles, California, 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, United States
- North Broward Hosp District — Fort Lauderdale, Florida, United States
- Goodgame Med Group — Maitland, Florida, United States
- Univ of Illinois — Chicago, Illinois, United States
- Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
- Baylor College of Medicine / Houston Veterans Adm Med Ctr — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.