NCT00002096

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients currently on either AZT or ddI receive ganciclovir therapy.

Conditions

• Cytomegalovirus Infections
• HIV Infections

Interventions

Type	Name	Description
DRUG	Zidovudine
DRUG	Didanosine
DRUG	Ganciclovir

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

3 sites across 1 country: United States