Status:

COMPLETED

Evaluation of Patients Who Have Not Had Success With Zidovudine

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

12+ years

Phase:

PHASE2

Brief Summary

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 be...

Detailed Description

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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

May 1 1995

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00001025

End Date

May 1 1995

Last Update

November 1 2021

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

3

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States, 951282699

4

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States, 943055107