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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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections; Gastrointestinal Diseases

Intervention: Ganciclovir (Drug)

Phase: Phase 2

Status: Completed

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

Official(s) and/or principal investigator(s):
Brosgart C, Study Chair
Craig C, Study Chair

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.

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

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

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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, 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

Bronx Lebanon Hosp Ctr, Bronx, New York 10456, 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

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States

Richmond AIDS Consortium, Richmond, Virginia 23298, United States

Additional Information

Related 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.


Last updated: September 28, 2013

Page last updated: August 20, 2015

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