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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical research trials and The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS clinical trial. Human subjects often get the best healthcare available for their The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS  The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.
Details: Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral agents. - Oral trimethoprim/sulfamethoxazole. - Aerosolized pentamidine. - Dapsone. - Fluconazole. - Rifabutin. - Filgrastim (G-CSF). - p24 vaccine. Patients must have: - Diagnosis of AIDS by CDC criteria. - Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis. - Visual acuity in the affected eye of >= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance. - Life expectancy of at least 3 months. - Consent of parent or guardian in patients less than 18 years of age. Prior Medication: Allowed: - Acyclovir. - Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Media opacity that precludes visualization of the fundus of both eyes. - Retinal detachment. - Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. - Active medical problems considered sufficient to hinder study compliance. - Known clinically significant allergy to probenecid. Concurrent Medication: Excluded: - Acyclovir (may be reinstituted following development of herpetic lesions). - Ganciclovir. - Foscarnet. - Amphotericin B. - Diuretics. - Aminoglycoside antibiotics. - CMV hyperimmune immunoglobulin. - Intravenous pentamidine. - Other nephrotoxic agents. - Other investigational drugs with potential nephrotoxicity. Prior Medication: Excluded: - Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis). Excluded within 1 week prior to study entry: - Amphotericin B. - Vidarabine. - Other nephrotoxic agents. - Aminoglycoside antibiotics. - Intravenous pentamidine. Drug or alcohol abuse.
Total Enrollment: 48
Location and Contact Information:
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Rochester Med Ctr
Rochester, New York, 14607
United States
Besselaar Associates
Princeton, New Jersey, 085406681
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Charing Cross and Westminster Med School
London SW 10, ,
United Kingdom
UCI Med Ctr
Orange, California, 92668
United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599
United States
Additional Information:
Study ID Numbers: 216A; GS-93-106
Study Start Date:
Record last reviewed: November 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002437
Other Hiv Infections Studies:
1. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
2. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
3. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
4. Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
5. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
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