Overview

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

Status:
Completed

Trial end date:
1995-02-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 1

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators:

Bristol-Myers Squibb
ICN Pharmaceuticals

Treatments:

Didanosine
Ribavirin