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.
Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Palo Alto Veterans Affairs Health Care System
Palo Alto, United StatesAIDS Community Research Consortium
Redwood City, United StatesMount Zion Med Ctr / UCSF
San Francisco, United States