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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002096

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1993
History of Changes
Purpose

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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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:

Enrollment: 24

Detailed Description:

Patients currently on either AZT or ddI receive ganciclovir therapy.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Hoffmann-La Roche  
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  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Didanosine
Ganciclovir
Drug Interactions
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Cytomegalovirus Infections
Zidovudine
Didanosine
Ganciclovir
Ganciclovir triphosphate

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.