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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002096
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1993
  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: 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:


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
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

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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Cytomegalovirus Infections
HIV Infections
HIV Seropositivity
Infection
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Ganciclovir
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014