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

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002096

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Infections HIV Infections	Drug: Zidovudine Drug: Didanosine Drug: Ganciclovir	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cytomegalovirus Infections Drug Reactions HIV/AIDS

Drug Information available for: Zidovudine Didanosine Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

24

Detailed Description:

Patients currently on either AZT or ddI receive ganciclovir therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002096

Locations

United States, California
Ctr for Special Immunology
Irvine, California, United States, 92718
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Publications:

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)

ClinicalTrials.gov Identifier:	NCT00002096 History of Changes
Other Study ID Numbers:	059E, ICM 1776
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Didanosine
Ganciclovir
Drug Interactions

Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections

Didanosine
Zidovudine
Ganciclovir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012