ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

ChemIDplus related topics:   Zidovudine    Ganciclovir    Ganciclovir sodium    Didanosine   

U.S. FDA Resources

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

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)
 

Study ID Numbers:   059E, ICM 1776
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002096
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Zidovudine
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Didanosine
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 06, 2008




Links to all studies - primarily for crawlers