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Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) Clinical research trials and Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT). Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) clinical trial. Subjects frequently obtain the most expert healthcare possible for their Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)  Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss. To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.
Details: Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with CD4+ T-cell counts < 100 cells/uL and often < 50 cells/uL. All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body. Discontinuation of therapy is associated with a prompt relapse of the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis generally occurs, at least with systemically administered anti-CMV drugs. The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet. Both are given by daily intravenous infusions and therefore require central venous catheters. The development of newer treatments has focused not only on efficacious treatments, but also on treatments that do not require central venous catheters. Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and intravenous cidofovir. In vitro data suggest that combination therapies are synergistic in inhibiting viral replication; these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure. The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis. Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2 weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate that regimen, an alternative systemic regimen will be recommended. Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss. The study will also assess other variables including mortality, blood CMV and HIV load, quality of life, and medical costs. Treatment assignment will not be masked to either patients or clinicians; however, reading of fundus photographs to determine both change in retinal involvement and progression will be masked.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Males and females age 13 years and older with diagnoses of AIDS and active CMV retinitis will be eligible. Patients must have a best corrected visual acuity of greater than or equal to 20/100 in at least one eye affected by CMV retinitis with at least one lesion 750 u or greater that can be photographed.
Total Enrollment:
Location and Contact Information:
Division of Infectious Diseases, Indiana University, Indianapolis
Indianapolis, Indiana, 46202-2879
United States
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-9217
United States
LAC/USC Medical Center, 5P21 Rand Schrader Clinic
Los Angeles, California, 90033
United States
Department of Ophthalmology, New York University Medical Center
New York City, New York, 10016
United States
Department of Ophthalmology, University of California, Irvine
Irvine, California, 92697-4375
United States
Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Jules Stein Eye Institute, University of California, Los Angeles
Los Angeles, California, 90095-7003
United States
Department of Ophthalmology, New York Hospital-Cornell Medical Center
New York City, New York, 10021
United States
Beckman Vision Center, University of California, San Francisco
San Francisco, California, 94143
United States
Cullen Eye Institute, Baylor College of Medicine
Houston, Texas, 77030
United States
Shiley Eye Center Center, 0946, University of California, San Diego
La Jolla, California, 92093-0946
United States
UMDNJ-New Jersey Medical School
Newark, New Jersey, 07103-2499
United States
Department of Ophthalmology, Mount Sinai School of Medicine
New York City, New York, 10029-6574
United States
LSU Eye Center, Louisiana State University Medical Center
New Orleans, Louisiana, 70112
United States
University of South Florida, MDC Box 21
Tampa, Florida, 33612-4799
United States
The Emory Clinic, Emory University
Atlanta, Georgia, 30322
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7030
United States
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136
United States
Department of Ophthalmology, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: NEI-42;
Study Start Date: May 1997
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000143
Other Cytomegalovirus Retinitis Studies:
1. A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
2. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
3. A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of Low Dose MN rsgp120/HIV-1 (Genentech) in Combination with QS21 Adjuvant or Alum in Healthy Adults
5. A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
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