A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
2 other identifiers
interventional
15
1 country
2
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- +8 more criteria
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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Bristol-Myers Squibbcollaborator
- ICN Pharmaceuticalscollaborator
Study Sites (2)
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Japour AJ, et al. A Phase I study of the safety, tolerance, & pharmacokinetics of combination didanosine/ribavirin for HIV disease (ACTG 231). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:103
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Japour AJ
- STUDY CHAIR
Lertora JJ
- STUDY CHAIR
Crumpacker C
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1995
Last Updated
October 28, 2021
Record last verified: 2021-10