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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity. To investigate antiviral activity of the combined regimen. Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).

Key facts

Study ID

NCT00000772

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

15

Expected to finish

1995-02-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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