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

Completed · Phase 1

Conditions studied: Cytomegalovirus Infections, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002096

Run by

Hoffmann-La Roche

People needed

24

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required:
• Concomitant AZT or ddI.
• Allowed:
• Probenecid.
• Aerosolized pentamidine.
• Patients must have:
• Asymptomatic HIV infection.
• CMV seropositivity or CMV culture positivity at present or at any time in the past.
• No history of CMV disease (e.g., retinitis, colitis) or any other AIDS-defining illness.
• Treatment with AZT or ddI for at least 1 month prior to study entry.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Uncontrolled diarrhea (three or more loose stools/day).
• Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
• AZT patients only:
• Deficiency in glucose-6-phosphate dehydrogenase.
• ddI patients only:
• Grade 2 or worse peripheral neuropathy.
• Concurrent Medication:
• Excluded:
• Combination antiretroviral therapy.
• G-CSF or GM-CSF.
• Acyclovir.
• Amphotericin B.
• Amikacin.
• Captopril.
• Carbamazepine.
• Cimetidine.
• Cyclosporine.
• Glutethimide.
• Gentamicin.
• Griseofulvin.
• Ibuprofen.
• Imipenem-Cilastatin.
• Lithium.

Where it is running

• Ctr for Special Immunology — Irvine, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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