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A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Primary Purpose

Cytomegalovirus Infections, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Biological Availability

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have the following: Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. Documented confirmation of present or past CMV infection. Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. Concurrent Medication: Excluded: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug. Patients with the following are excluded: Any concomitant conditions listed in Exclusion Co-Existing Conditions. Karnofsky score < 70. Hypersensitivity to acyclovir. Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule. Prior Medication: Excluded: Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease. Excluded within 4 days of study entry: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT).

Sites / Locations

  • Davies Med Ctr
  • Georgetown Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002251
Brief Title
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
Official Title
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
Study Type
Interventional

2. Study Status

Record Verification Date
May 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Biological Availability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have the following: Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. Documented confirmation of present or past CMV infection. Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. Concurrent Medication: Excluded: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug. Patients with the following are excluded: Any concomitant conditions listed in Exclusion Co-Existing Conditions. Karnofsky score < 70. Hypersensitivity to acyclovir. Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule. Prior Medication: Excluded: Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease. Excluded within 4 days of study entry: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT).
Facility Information:
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8690817
Citation
Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x.
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A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

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