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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.
Study NCT00002096.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
Official Title  A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cytomegalovirus Infections
HIV Infections
Intervention  Drug: Zidovudine
Drug: Didanosine
Drug: Ganciclovir
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  24
Start Date 
Completion Date
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).

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002096
Organization ID 059E
Secondary IDs †† ICM 1776
Study Sponsor  Hoffmann-La Roche
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date November 1993
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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