NCT00001062

Brief Summary

To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients. A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

6 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

Study Completion

Last participant's last visit for all outcomes

January 1, 1998

Completed
1.8 years until next milestone

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

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

Cytomegalovirus RetinitisHIV Infections

Keywords

Infusions, IntravenousGanciclovirAdministration, OralAcquired Immunodeficiency SyndromeAntiviral AgentsCytomegalovirus Retinitis

Interventions

GanciclovirDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Erythropoietin, G-CSF, or GM-CSF.
  • Antiretrovirals.
  • Patients must have:
  • HIV infection.
  • Evaluable CMV retinitis with photographable lesions.
  • Life expectancy of at least 6 months.
  • No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
  • Corneal, lens, or vitreous opacification precluding funduscopic exam.
  • Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
  • Inability to obtain temporary IV access.
  • Requirement for permanent catheters for IV ganciclovir administration.
  • Uncontrolled diarrhea or nausea preventing ingestion of medicine.
  • Known hypersensitivity to IV or oral ganciclovir.
  • Concurrent Medication:
  • Excluded:
  • Immunomodulators.
  • Biologic response modifiers.
  • Interferon.
  • Related investigational agents.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Cornell University A2201

New York, New York, 10021, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.

    PMID: 9110064BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus RetinitisHIV InfectionsMultiple Acyl Coenzyme A Dehydrogenase DeficiencyAcquired Immunodeficiency Syndrome

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesEye DiseasesRetinitisRetinal DiseasesBlood-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)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Holland GN

    STUDY CHAIR

  • Hardy WD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

January 1, 1998

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(6)