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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Infusions, Intravenous, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA CARE Center CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Johns Hopkins Adult AIDS CRS
  • Cornell University A2201
  • Unc Aids Crs
  • University of Washington AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001062
Brief Title
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Official Title
A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Infusions, Intravenous, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holland GN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hardy WD
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Cornell University A2201
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9110064
Citation
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.
Results Reference
background

Learn more about this trial

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

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