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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001034 |
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 II |
MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
Drug Information available for: | Ganciclovir Ganciclovir sodium |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 850 |
Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 60 days prior to study entry:
Excluded within 2 weeks prior to study entry:
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, 802044507 | |||||
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 | |||||
Henry Ford Hosp | |||||
Detroit, Michigan, United States, 48202 | |||||
Comprehensive AIDS Alliance of Detroit | |||||
Detroit, Michigan, United States, 48201 | |||||
United States, New Jersey | |||||
Schering - Plough Corp | |||||
Kenilworth, New Jersey, United States, 07033 | |||||
North Jersey Community Research Initiative | |||||
Newark, New Jersey, United States, 071032842 | |||||
United States, New York | |||||
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |||||
New York, New York, United States, 10037 | |||||
Bronx Lebanon Hosp Ctr | |||||
Bronx, New York, United States, 10456 | |||||
Clinical Directors Network of Region II | |||||
New York, New York, United States, 10011 | |||||
Addiction Research and Treatment Corp | |||||
Brooklyn, New York, United States, 11201 | |||||
United States, Oregon | |||||
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |||||
Portland, Oregon, United States, 972109951 | |||||
United States, Virginia | |||||
Richmond AIDS Consortium | |||||
Richmond, Virginia, United States, 23298 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Hoffmann-La Roche |
Study Chair: | Brosgart C | |
Study Chair: | Craig C |
Click here for more information about Ganciclovir 
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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)
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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.
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Study ID Numbers: | CPCRA 023 |
First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00001034 |
Health Authority: | United States: Federal Government |
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