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

NCT ID: NCT00002096

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Cytomegalovirus Infections; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Zidovudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Ganciclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
• Methicillin.
• Methotrexate.
• Naproxen.
• Pentamidine (Pentam 300) (Aerosolized drug permitted).
• Phenacetin.
• Phenobarbital.
• Phenytoin.
• Piroxicam.
• Ribavirin.
• Rifampin.
• Tobramycin.
• Vidarabine.
• Zalcitabine.
• Other investigational drugs.

Patients with the following prior conditions are excluded:

• History of hypersensitivity to acyclovir or ganciclovir.
• AZT patients only:
• History of gout, uric acid, kidney stones, peptic ulcer or porphyria.
• ddI patients only:
• History of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy.

Prior Medication:

Excluded:

• Combination antiretroviral therapy within 1 month prior to study entry.

Required:

• AZT at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). OR
• ddI at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry).

History of alcoholism (in ddI patients).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

ICM 1776

Identifier Type: -

Identifier Source: secondary_id

059E

Identifier Type: -

Identifier Source: org_study_id