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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000894 |
To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
Condition | Intervention | Phase |
Cytomegalovirus Retinitis HIV Infections |
Drug: Cidofovir Drug: Probenecid Drug: Ganciclovir |
Phase IV |
MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
Drug Information available for: | Ganciclovir Ganciclovir sodium Probenecid Cidofovir |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) |
Estimated Enrollment: | 300 |
While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.
After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |||||
UCLA CARE Ctr | |||||
Los Angeles, California, United States, 90095 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
United States, Florida | |||||
Univ of Miami / Bascom Palmer Eye Institute | |||||
Miami, Florida, United States, 33136 | |||||
United States, Georgia | |||||
Emory Eye Clinic | |||||
Atlanta, Georgia, United States, 30322 | |||||
United States, Illinois | |||||
Northwestern Univ / SOCA | |||||
Chicago, Illinois, United States, 60611 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, New York | |||||
Cornell Univ Med Ctr | |||||
New York, New York, United States, 10021 | |||||
New York Hosp / Cornell Med Ctr | |||||
New York, New York, United States, 10021 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 | |||||
United States, Texas | |||||
Univ of Texas Galveston | |||||
Galveston, Texas, United States, 775550435 |
Click here for more information about Ganciclovir 
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Haga clic aquí para ver información sobre este ensayo clínico en español. 
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Study ID Numbers: | ACTG 350 |
First Received: | November 2, 1999 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00000894 |
Health Authority: | United States: Federal Government |
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