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Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis Clinical research trials and Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis. Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis clinical trial. Subjects typically recieve the finest healthcare available for their Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis  Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis
Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 300
Location and Contact Information:
UCLA CARE Ctr
Los Angeles, California, 90095
United States
New York Hosp / Cornell Med Ctr
New York City, New York, 10021
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Miami / Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Emory Eye Clinic
Atlanta, Georgia, 30322
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 350;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000894
Other Hiv Infections Studies:
1. Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma
2. An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
3. A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies with Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
4. A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
5. A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
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Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis
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