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
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
2 other identifiers
interventional
850
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
August 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Community Consortium of San Francisco
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Schering - Plough Corp
Kenilworth, New Jersey, 07033, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Clinical Directors Network of Region II
New York, New York, 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Richmond AIDS Consortium
Richmond, Virginia, 23298, United States
Related Publications (2)
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)
BACKGROUNDBrosgart 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.
PMID: 9517989BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Brosgart C
- STUDY CHAIR
Craig C
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 1995
Last Updated
November 4, 2021
Record last verified: 2021-10