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

June 23, 2005 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients currently on either AZT or ddI receive ganciclovir therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 1993

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 059E
  • ICM 1776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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