|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb ICN Pharmaceuticals |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000772 |
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).
Condition | Intervention | Phase |
HIV Infections |
Drug: Ribavirin Drug: Didanosine |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Didanosine Ribavirin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals |
Estimated Enrollment: | 15 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Active alcohol abuse.
United States, Connecticut | |||||
Yale Univ / New Haven | |||||
New Haven, Connecticut, United States, 065102483 | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Med Ctr | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, Minnesota | |||||
Univ of Minnesota | |||||
Minneapolis, Minnesota, United States, 55455 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Bristol-Myers Squibb |
ICN Pharmaceuticals |
Study Chair: | Japour AJ | |
Study Chair: | Lertora JJ | |
Study Chair: | Crumpacker C |
Click here for more information about Didanosine 
  |
Click here for more information about Ribavirin 
  |
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
  |
Study ID Numbers: | ACTG 231 |
First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000772 |
Health Authority: | United States: Federal Government |
|
|
|
|
|