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A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Roche Global Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, 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: Topical and ophthalmic nucleoside analogues. Patients must have: HIV positive. No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis. Currently stable retinitis. Prior Medication: Allowed: Foscarnet prior to the 4 weeks of intravenous induction therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Persistent or clinically significant diarrhea, nausea, or abdominal pain. Severe odynophagia. Other gastrointestinal (GI) symptoms or uncontrolled GI disease. Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis). Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments. Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance. Concurrent Medication: Excluded: Acyclovir sodium (Zovirax) by any route other than topical. Valacyclovir. Brovavir. Vidarabine. Amantadine hydrochloride. Cytarabine. Idoxuridine. Ribavirin. Interferon. Foscarnet (non-nucleoside pyrophosphate analogue). CMV hyperimmune globulin. Soluble CD4. Trichosanthin (Compound Q). Imipenem-cilastatin. Isoprinosine. Levamisole. Other investigational drugs. Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: More than three induction regimens with intravenous anti-CMV therapy. Any prior oral ganciclovir.

Sites / Locations

  • Univ of Alabama at Birmingham / AIDS Outpatient Clinic
  • McDowell Clinic
  • Dr Ken Fisher
  • Univ of Arizona / Health Science Ctr
  • East Bay AIDS Ctr
  • AIDS Clinical Research Ctr / UCLA Med Ctr
  • UCSD Med Ctr / Pediatrics
  • Davies Med Ctr
  • Mount Zion Med Ctr / UCSF
  • San Francisco Veterans Administration Med Ctr
  • George Washington Univ Med Ctr
  • Community Research Initiative
  • AIDS Research Consortium of Atlanta
  • Margo Heath - Chiozzi
  • Univ of Maryland School of Medicine
  • AIDS Clinical Trials Unit
  • HIV Wellness Ctr / Univ Med Ctr
  • Univ of New Mexico
  • AIDS Wellness Clinic
  • Dr Dorothy Friedberg
  • Saint Luke's - Roosevelt Hosp Ctr
  • New York Hosp - Cornell Med Ctr
  • Univ of North Carolina School of Medicine
  • Nalle Clinic
  • Case Western Reserve Univ
  • Ohio State Univ Hosp
  • Associates Med and Mental Health
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Buckley Braffman Stern Med Associates
  • Austin Infectious Disease Consultants
  • N Texas Ctr for AIDS & Clin Rsch
  • Texas Tech Health Sciences Ctr
  • Dr Daniel Barbero
  • Infectious Diseases Association of Houston
  • Audie L Murphy Veterans Administration Hosp
  • Saint Paul's Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Roche Global Development
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1. Study Identification

Unique Protocol Identification Number
NCT00002330
Brief Title
A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Official Title
A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roche Global Development

4. Oversight

5. Study Description

Brief Summary
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Detailed Description
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

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, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
280 (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: Topical and ophthalmic nucleoside analogues. Patients must have: HIV positive. No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis. Currently stable retinitis. Prior Medication: Allowed: Foscarnet prior to the 4 weeks of intravenous induction therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Persistent or clinically significant diarrhea, nausea, or abdominal pain. Severe odynophagia. Other gastrointestinal (GI) symptoms or uncontrolled GI disease. Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis). Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments. Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance. Concurrent Medication: Excluded: Acyclovir sodium (Zovirax) by any route other than topical. Valacyclovir. Brovavir. Vidarabine. Amantadine hydrochloride. Cytarabine. Idoxuridine. Ribavirin. Interferon. Foscarnet (non-nucleoside pyrophosphate analogue). CMV hyperimmune globulin. Soluble CD4. Trichosanthin (Compound Q). Imipenem-cilastatin. Isoprinosine. Levamisole. Other investigational drugs. Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: More than three induction regimens with intravenous anti-CMV therapy. Any prior oral ganciclovir.
Facility Information:
Facility Name
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
McDowell Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Dr Ken Fisher
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
AIDS Clinical Research Ctr / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Mount Zion Med Ctr / UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
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
Community Research Initiative
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Margo Heath - Chiozzi
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
AIDS Clinical Trials Unit
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
HIV Wellness Ctr / Univ Med Ctr
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Univ of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
AIDS Wellness Clinic
City
Sante Fe
State/Province
New Mexico
ZIP/Postal Code
87501
Country
United States
Facility Name
Dr Dorothy Friedberg
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
282072198
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Associates Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Austin Infectious Disease Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
N Texas Ctr for AIDS & Clin Rsch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Texas Tech Health Sciences Ctr
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Dr Daniel Barbero
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Infectious Diseases Association of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)
Results Reference
background

Learn more about this trial

A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

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