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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Retinitis HIV Infections Gastrointestinal Diseases	Drug: Ganciclovir	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ganciclovir Ganciclovir sodium

Genetic and Rare Diseases Information Center resources: Cytomegalic Inclusion Disease Cytomegalovirus Retinitis

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Estimated Enrollment:	850
Study Completion Date:	August 1995

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.

Eligibility


Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001034

Locations


United States, California
Community Consortium of San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Michigan
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New Jersey
Schering - Plough Corp
Kenilworth, New Jersey, United States, 07033
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Clinical Directors Network of Region II
New York, New York, United States, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Hoffmann-La Roche

Investigators


Study Chair:	Brosgart C
Study Chair:	Craig C

More Information

Publications:

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)

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.


Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001034 History of Changes
Other Study ID Numbers:	CPCRA 023, 11573
Study First Received:	November 2, 1999
Last Updated:	September 28, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):


Retinitis Ganciclovir Cytomegalovirus Infections	Administration, Oral Acquired Immunodeficiency Syndrome Gastrointestinal System

Additional relevant MeSH terms:


Cytomegalovirus Retinitis Digestive System Diseases Gastrointestinal Diseases Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Herpesviridae Infections	Retinal Diseases Retinitis Virus Diseases Ganciclovir Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015