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A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 3
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 Retinitis, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir. Didanosine (ddI) may be continued or initiated in any patient during the study. Topical acyclovir. Topical ophthalmics. Aerosolized pentamidine. Patients must have: AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV. Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea. Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex. Life expectancy of at least 4 months. Exclusion Criteria Co-existing Condition: Patients with ocular conditions requiring immediate surgical correction are excluded. Concurrent Medication: Excluded during first 4 weeks of ganciclovir treatment: Zidovudine (AZT). Excluded: Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines. Patients with the following are excluded: Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea). Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment. Demonstrated hypersensitivity to acyclovir. Prior Medication: Excluded: - Previous treatment with anti-cytomegalovirus therapy.

Sites / Locations

  • Univ of California / San Diego Treatment Ctr
  • Mount Zion Med Ctr
  • Stanford at Kaiser / Kaiser Permanente Med Ctr
  • Pacific Presbyterian
  • Mills Hosp
  • Stanford Univ School of Medicine
  • George Washington Univ Med Ctr
  • Northwestern Univ Med School
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Indiana Univ Hosp
  • Henry Ford Hosp
  • Univ of Minnesota
  • Kansas City Veterans Administration Med Ctr
  • Washington Univ Med Ctr
  • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
  • New York Univ Med Ctr / Dept of Environmental Med
  • Cornell Univ Med Ctr
  • Holmes Hosp / Univ of Cincinnati Med Ctr
  • Univ TX Galveston Med Branch
  • Plaza Med Ctr
  • Infectious Diseases Association of Houston / Methodist Hosp
  • Infectious Disease Physicians Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
March 11, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00000688
Brief Title
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Official Title
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 1995 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis. CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.
Detailed Description
CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG. Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
180 (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: Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir. Didanosine (ddI) may be continued or initiated in any patient during the study. Topical acyclovir. Topical ophthalmics. Aerosolized pentamidine. Patients must have: AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV. Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea. Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex. Life expectancy of at least 4 months. Exclusion Criteria Co-existing Condition: Patients with ocular conditions requiring immediate surgical correction are excluded. Concurrent Medication: Excluded during first 4 weeks of ganciclovir treatment: Zidovudine (AZT). Excluded: Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines. Patients with the following are excluded: Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea). Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment. Demonstrated hypersensitivity to acyclovir. Prior Medication: Excluded: - Previous treatment with anti-cytomegalovirus therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spector SA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jabs D
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Mount Zion Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford at Kaiser / Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Presbyterian
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Mills Hosp
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Kansas City Veterans Administration Med Ctr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Washington Univ Med Ctr
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New York Univ Med Ctr / Dept of Environmental Med
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Holmes Hosp / Univ of Cincinnati Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Plaza Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Infectious Diseases Association of Houston / Methodist Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8394858
Citation
Spector SA, Weingeist T, Pollard RB, Dieterich DT, Samo T, Benson CA, Busch DF, Freeman WR, Montague P, Kaplan HJ, et al. A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS. AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1993 Sep;168(3):557-63. doi: 10.1093/infdis/168.3.557.
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A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

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