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

Phase 1

Completed

• Conditions: Cytomegalovirus Infections; HIV Infections

• Registration Number: NCT00002096
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Study Timeline

• Status Verified: 1993-11
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Georgetown Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Ctr for Special Immunology; 🇺🇸 Irvine, California, United States

Univ TX Galveston Med Branch; 🇺🇸 Galveston, Texas, United States