A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001062
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 25
Study Completion Date: January 1998
Detailed Description:

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.

Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles (16 weeks). If CMV retinitis fails to arrest after initial induction, IV ganciclovir is administered for an additional 2 weeks.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  • CMV prophylaxis.
  • Systemic acyclovir.
  • Any nephrotoxic agent.
  • Any concomitant therapy that would prohibit use of ganciclovir.

Prior Medication:

Excluded:

  • Prior treatment for CMV retinitis.
  • More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001062

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
United States, Illinois
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, New York
Cornell University A2201
New York, New York, United States, 10021
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Investigators
Study Chair: Holland GN
Study Chair: Hardy WD
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001062     History of Changes
Other Study ID Numbers: ACTG 278, 11254
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Infusions, Intravenous
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014