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Evaluation of Patients Who Have Not Had Success With Zidovudine
Not Recruiting
Trial ID: NCT00001025
Purpose
To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral
load (as determined by plasma viremia and quantitative endpoint dilution). To determine the
relationship between viral load and susceptibility during different antiretroviral therapy
strategies. To correlate measures of viral load and short term clinical and laboratory
markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the
different therapy arms.
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent
of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical
significance of in vitro AZT resistance, it is necessary to distinguish between clinical
failure caused by AZT resistance and clinical decompensation caused by other factors.
Official Title
A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance
Eligibility
Inclusion Criteria
Concurrent Medication:
Allowed:
- Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium
tuberculosis, or Herpes simplex virus, or against other opportunistic infections as
indicated.
- Corticosteroids for no longer than 21 days (only as part of PCP therapy).
- Erythropoietin and G-CSF.
Patients must have:
- Documented HIV-seropositivity.
- CD4 count 100 - 300 cells/mm3.
- Prior continuous AZT dose = or > 300 mg/day for 1 year or longer.
Prior Medication: Required:
- AZT for at least 1 year prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Medical contraindication or is considered noncompliant in the opinion of the
investigator.
- Peripheral neuropathy = or > grade 2.
Concurrent Medication:
Excluded:
- Anti-HIV agents other than study drugs.
- Biologic response modifiers (other than erythropoietin or G-CSF).
- Systemic cytotoxic chemotherapy.
- Regularly prescribed medications (such as antipyretics, analgesics, allergy
medications) that are associated with an increased risk of pancreatitis, peripheral
neuropathy, or bone marrow suppression.
Concurrent Treatment:
Excluded:
- Radiation therapy.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis, gout, or uric acid nephropathy.
Prior Medication:
Excluded:
- Other antiretrovirals besides AZT.
- ddI or ddC for more than 30 days within the past year or any time within 3 months
prior to study entry.
- Acute therapy for an infection or other medical illness within 14 days prior to study
entry.
Intervention(s):
drug: Zidovudine
drug: Didanosine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305