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