HIV Infections Clinical Trial
Official title:
Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
NCT number | NCT00000894 |
Other study ID # | ACTG 350 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | November 2, 1999 |
Last updated | February 22, 2011 |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | |
Est. primary completion date | June 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
Inclusion Criteria You may be eligible for this study if you: - Are 13 years of age or older (parent or guardian consent required if under 18). - Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study. - Have AIDS. - Have CMV retinitis. Exclusion Criteria You will not be eligible for this study if you: - Have a history of heart or kidney disease. - Have medical problems which would prevent you from completing the study. - Are pregnant. |
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory Eye Clinic | Atlanta | Georgia |
United States | Johns Hopkins Hosp | Baltimore | Maryland |
United States | Univ of North Carolina | Chapel Hill | North Carolina |
United States | Northwestern Univ / SOCA | Chicago | Illinois |
United States | Univ of Texas Galveston | Galveston | Texas |
United States | UCLA CARE Ctr | Los Angeles | California |
United States | Univ of Southern California / LA County USC Med Ctr | Los Angeles | California |
United States | Univ of Miami / Bascom Palmer Eye Institute | Miami | Florida |
United States | Charity Hosp / Tulane Univ Med School | New Orleans | Louisiana |
United States | Cornell Univ Med Ctr | New York | New York |
United States | New York Hosp / Cornell Med Ctr | New York | New York |
United States | Julio Arroyo | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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