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Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component Clinical research trials and Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component. Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component  Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Johns Hopkins University
Synopsis: To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3. CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
Details: CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3. Patients are assigned to one of two groups: (1) Patients with any retinitis in zone 1 or patients with retinitis involving 25 percent or more of zones 2 and 3; and (2) Patients in whom retinitis is confined to less than 25 percent of zones 2 and 3 of the retina. Half the patients in group 1 get immediate treatment with ganciclovir; the other half receive immediate treatment with foscarnet. Patients in group 2 are treated with foscarnet or ganciclovir either immediately or treatment is deferred. If patients in group 2 have strong preferences regarding when therapy is instituted, they may elect immediate treatment or deferral of treatment.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical anti-Herpesvirus agents. - Zidovudine (AZT) for patients in deferral or foscarnet treatment groups: - 100 mg every 4 hours. For patients on ganciclovir: - 100 mg every 8 hours. - Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis. - It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops. Patients must have: - Diagnosis of AIDS by CDC criteria or a documented HIV infection. - Cytomegalovirus (CMV) retinitis that does not require surgical intervention diagnosed in one or both eyes by a SOCA-certified ophthalmologist. - The means available for compliance with follow-up visits (including a caregiver if necessary). - Must consent to study or consent of parent or guardian if less than 18 years of age. - Willingness to take reduced dose of zidovudine (AZT) if dictated by treatment assignment. - Willingness to discontinue other systemic treatments for Herpesvirus infections while receiving foscarnet or ganciclovir. Prior Medication: Allowed: - Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Sufficient media opacities to preclude fundus photographs in both eyes. Concurrent Medication: Excluded: - Other systemic treatments for Herpesvirus infections. - Other anti-cytomegalovirus therapy. - Excluded with foscarnet: - Parenteral pentamidine, amphotericin B, or aminoglycosides. - Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible. Patients with the following are excluded: - Sufficient media opacities to preclude fundus photographs in both eyes. - Known or suspected allergy to one of the study medications. Prior Medication: Excluded: - Foscarnet or ganciclovir used previously to treat cytomegalovirus (CMV) retinitis. - Excluded within 14 days of study entry: - CMV hyperimmunoglobulin or other anti-CMV agents. - Excluded within the past 28 days: - Anti-CMV therapy. Active intravenous drug or alcohol abuse, sufficient in the investigator's opinion to prevent adequate compliance with study therapy and follow-up.
Total Enrollment: 240
Location and Contact Information:
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143
United States
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946
United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611
United States
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
New York City, New York, 10021
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217
United States
New York Univ Med Ctr / SOCA
New York City, New York, 10016
United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003
United States
Mount Sinai Med Ctr / SOCA
New York City, New York, 100296574
United States
Additional Information:
Study ID Numbers: ACTG 129; FDA 46A,FDA/00095
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000665
Other Hiv Infections Studies:
1. A Study of a Combination of Four Drugs in Patients with Recent HIV Infection
2. The Healthy Life Choices Project in HIV-Positive Patients
3. A Study of Trimetrexate Plus Leucovorin in Children with Pneumocystis Carinii Pneumonia
4. A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
5. Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
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Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
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