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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Primary Purpose

Cytomegalovirus Infections, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring 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 or ophthalmic nucleoside analogs. Patients must have: Confirmation of HIV infection. Documented CMV infection. No past or present CMV disease (e.g., retinitis, colitis, esophagitis). Adequate visualization of the retina of both eyes by ophthalmologist. CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication). Inability to comply with protocol. Concurrent Medication: Excluded: The following nucleoside analogs: IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine. FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC. Imipenem-cilastatin (Primaxin). Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir. Prior Medication: Excluded within the past 60 days: Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.

Sites / Locations

  • East Bay AIDS Ctr
  • Kraus - Beer Med Group
  • UCSD
  • Davies Med Ctr / c/o HIV Institute
  • Mount Zion Med Ctr
  • San Francisco Veterans Administration Med Ctr
  • Harbor - UCLA Med Ctr
  • Georgetown Univ Med Ctr
  • Community Research Initiative
  • AIDS Research Consortium of Atlanta
  • Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
  • Beth Israel Hosp
  • Kaplan Cancer Ctr / New York Univ Med Ctr
  • St Lukes - Roosevelt Hosp Ctr
  • Cornell Univ Med College / New York Hosp
  • Buckley Braffman Stern Med Associates
  • Univ of Pittsburgh / Graduate School of Public Health
  • Oak Lawn Physicians Group
  • Infectious Diseases Association of Houston

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002095
Brief Title
A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
Official Title
A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
Study Type
Interventional

2. Study Status

Record Verification Date
November 1993
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
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
700 (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 or ophthalmic nucleoside analogs. Patients must have: Confirmation of HIV infection. Documented CMV infection. No past or present CMV disease (e.g., retinitis, colitis, esophagitis). Adequate visualization of the retina of both eyes by ophthalmologist. CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication). Inability to comply with protocol. Concurrent Medication: Excluded: The following nucleoside analogs: IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine. FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC. Imipenem-cilastatin (Primaxin). Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir. Prior Medication: Excluded within the past 60 days: Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Kraus - Beer Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Mount Zion Med Ctr
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
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
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
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Beth Israel Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Kaplan Cancer Ctr / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St Lukes - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cornell Univ Med College / New York Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Pittsburgh / Graduate School of Public Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Oak Lawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Infectious Diseases Association of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8618603
Citation
Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.
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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

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