A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

HIV Infections Clinical Trial

Official title:

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002096
• Other study ID #: 059E
• Secondary ID: ICM 1776
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients currently on either AZT or ddI receive ganciclovir therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Infection

Intervention

Drug:
• Zidovudine

• Didanosine

• Ganciclovir

Locations

Country	Name	City	State
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Ctr for Special Immunology	Irvine	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)