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The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections, Gastrointestinal Diseases

Status
Completed
Phase
Phase 2
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, Ganciclovir, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Gastrointestinal System

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Anti-PCP prophylaxis. Maintenance or prophylaxis therapy for other opportunistic infections besides CMV. Patients must have: Working diagnosis of HIV infection. CD4 count <= 100 cells/mm3. Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute life-threatening illness. Active lymphoma. Hypersensitivity to acyclovir. Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements. Concurrent Medication: Excluded: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Foscarnet. Intravenous ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity. Prior Medication: Excluded within 60 days prior to study entry: Foscarnet. Excluded within 2 weeks prior to study entry: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity.

Sites / Locations

  • Community Consortium of San Francisco
  • Denver CPCRA / Denver Public Hlth
  • Wilmington Hosp / Med Ctr of Delaware
  • Veterans Administration Med Ctr / Regional AIDS Program
  • AIDS Research Consortium of Atlanta
  • AIDS Research Alliance - Chicago
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
  • Comprehensive AIDS Alliance of Detroit
  • Henry Ford Hosp
  • Schering - Plough Corp
  • North Jersey Community Research Initiative
  • Bronx Lebanon Hosp Ctr
  • Addiction Research and Treatment Corp
  • Clinical Directors Network of Region II
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Richmond AIDS Consortium

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)
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00001034
Brief Title
The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
Official Title
A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression
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
August 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression. The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.
Detailed Description
The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis. Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections, Gastrointestinal Diseases
Keywords
Retinitis, Ganciclovir, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Gastrointestinal System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
850 (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: Antiretroviral therapy. Anti-PCP prophylaxis. Maintenance or prophylaxis therapy for other opportunistic infections besides CMV. Patients must have: Working diagnosis of HIV infection. CD4 count <= 100 cells/mm3. Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute life-threatening illness. Active lymphoma. Hypersensitivity to acyclovir. Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements. Concurrent Medication: Excluded: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Foscarnet. Intravenous ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity. Prior Medication: Excluded within 60 days prior to study entry: Foscarnet. Excluded within 2 weeks prior to study entry: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brosgart C
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Craig C
Official's Role
Study Chair
Facility Information:
Facility Name
Community Consortium of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver CPCRA / Denver Public Hlth
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Wilmington Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Veterans Administration Med Ctr / Regional AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Comprehensive AIDS Alliance of Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Schering - Plough Corp
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Clinical Directors Network of Region II
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
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
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Brosgart C, Craig C, Louis TA, Hillman D, Costanzo L, Timpone J, Scott J, Nunley F, Stempien MJ. Design and demographics in a multicenter trial of cytomegalovirus (CMV) prophylaxis in advanced HIV disease. Int Conf AIDS. 1994 Aug 7-12;10(2):10 (abstract no 331B)
Results Reference
background
PubMed Identifier
9517989
Citation
Brosgart CL, Louis TA, Hillman DW, Craig CP, Alston B, Fisher E, Abrams DI, Luskin-Hawk RL, Sampson JH, Ward DJ, Thompson MA, Torres RA. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 1998 Feb 12;12(3):269-77. doi: 10.1097/00002030-199803000-00004.
Results Reference
background

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The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

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