NCT00002096

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1993

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus InfectionsHIV Infections

Keywords

DidanosineGanciclovirDrug InteractionsCytomegalovirus InfectionsAcquired Immunodeficiency SyndromeZidovudine

Interventions

ZidovudineDRUG
DidanosineDRUG
GanciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +37 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ctr for Special Immunology

Irvine, California, 92718, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Univ TX Galveston Med Branch

Galveston, Texas, 77550, United States

Location

Related 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)

    BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus InfectionsHIV InfectionsMultiple Acyl Coenzyme A Dehydrogenase DeficiencyAcquired Immunodeficiency Syndrome

Interventions

ZidovudineDidanosineGanciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosidesAcyclovirGuanineHypoxanthinesPurinones

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1993-11

Locations

US(3)