A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Ribavirin (Drug); Didanosine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Japour AJ, Study Chair
Lertora JJ, Study Chair
Crumpacker C, Study Chair
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).
Clinical Details
Official title: A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
Study design: Treatment, Open Label, Safety Study
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 receive ddI alone for 4 weeks, followed by 8 weeks of combination ddI/ribavirin.
Patients who complete the first 12 weeks without major toxicity may receive an additional 12
weeks of combination therapy on an optional basis. Patients are followed for 60 days after
the last treatment visit.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Yale Univ / New Haven, New Haven, Connecticut 065102483, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States
Univ of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information
Click here for more information about Didanosine Click here for more information about Ribavirin
Related publications: 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
Last updated: June 23, 2005
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