drugset / Trial / NCT00002096

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

NCT00002096

Phase 1 Completed 24 enrolled Hoffmann-La Roche
Treatment

Summary

To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.

Timeline

Start
Primary completion
Completion

Publications

  • Background Gaines K, Wong R, Jung D, Cimoch P, Lavelle J, Pollard R. Pharmacokinetic interactions with oral ganciclovir: zidovudine, didanosine, probenecid. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 004B)

Drugs

EvaluationDrugModalityDoseRoute
Subject Didanosine Small molecule
Subject Ganciclovir Small molecule
Subject Zidovudine Small molecule