A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1993
History of Changes
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.
Drug : Zidovudine
Drug : Didanosine
Drug : Ganciclovir
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:
Patients currently on either AZT or ddI receive ganciclovir therapy.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Concomitant AZT or ddI.
- Aerosolized pentamidine.
- 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.
- 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.
- Combination antiretroviral therapy.
- G-CSF or GM-CSF.
- Amphotericin B.
- Pentamidine (Pentam 300) (Aerosolized drug permitted).
- Other investigational drugs.
- 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.
- Combination antiretroviral therapy within 1 month prior to study entry.
- 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
Patients must have:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
History of alcoholism (in ddI patients).
Contacts and LocationsChoosing 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 Show More
|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 CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002096 History of Changes|
|Other Study ID Numbers:||059E|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Didanosine
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 23, 2018
This information is provided by ClinicalTrials.gov.