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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1
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
2
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455