Status:

COMPLETED

A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

ICN Pharmaceuticals

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of c...

Detailed Description

Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT). Patients recei...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Stable maintenance or prophylaxis therapy for opportunistic infection, if such therapy was administered for at least 30 days prior to study entry.
  • Isoniazid for chemoprophylaxis against Mycobacterium tuberculosis.
  • Fluconazole for mucosal candidiasis or cryptococcosis.
  • Acyclovir (up to 1.0 g/day).
  • Dapsone.
  • Ketoconazole.
  • Quinolones.
  • Tetracycline.
  • Vitamins and herbal therapies.
  • Antibiotics as clinically indicated.
  • Systemic corticosteroids for < 21 days for acute problems.
  • Regularly prescribed medications.

Patients must have:

  • HIV positivity by ELISA confirmed by Western blot.
  • CD4 count < 500 cells/mm3 within 30 days prior to study entry.
  • No active opportunistic infections requiring treatment (patients on stable maintenance and prophylaxis therapy for opportunistic infections for at least 30 days are permitted).

NOTE:

  • Enrollment of women is encouraged.

Prior Medication:

Allowed:

  • Prior stable maintenance or prophylaxis therapy for opportunistic infection, if administered for at least 30 days prior to study entry.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Concurrent rifampin or rifabutin.
  • Other anti-HIV drugs and investigational agents.
  • Biological response modifiers.
  • Ganciclovir or foscarnet.
  • Systemic cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

  • Concurrent radiation therapy other than limited localized therapy to the skin.

Patients with the following prior conditions are excluded:

  • History of peripheral neuropathy.
  • History of pancreatitis or active liver disease.

Prior Medication:

Excluded:

  • Prior ddI.
  • Ribavirin within 60 days prior to study entry.
  • AZT or ddC within 2 weeks prior to study entry.

Prior Treatment:

Excluded:

  • Transfusion within 2 weeks prior to study entry.

Active alcohol abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1995

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00000772

End Date

February 1 1995

Last Update

October 28 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States, 02215

2

University of Minnesota, ACTU

Minneapolis, Minnesota, United States, 55455