A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Infections; HIV Infections
Intervention: Zidovudine (Drug); Didanosine (Drug); Ganciclovir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche
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.
Clinical Details
Official title: A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
Study design: Treatment, Safety Study
Detailed description:
Patients currently on either AZT or ddI receive ganciclovir therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Ctr for Special Immunology, Irvine, California 92718, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Additional Information
Related 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)
Last updated: June 23, 2005
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