Evaluation of Patients Who Have Not Had Success With Zidovudine

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, wi...

Gender

ALL

Eligibility criteria

• • 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.

Trial Officials