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Home > "A" Clinical Trials Conditions > A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir  A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 20
Location and Contact Information:
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Additional Information:
Study ID Numbers: 059A; ICM 1775
Study Start Date:
Record last reviewed: May 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002251
Other Hiv Infections Studies:
1. A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients with AIDS
2. A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
3. A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies with Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
4. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
5. HIV Prevention Preparedness Study in Russia, China, and India
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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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