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Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Clinical research trials and Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081). Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) clinical trial. Human subjects frequently get the finest healthcare available for their Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)  Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
For Condition: Candidiasis,Mycoses,HIV Infections
Status: Completed
Sponsor(s): Pfizer , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
Details: Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective. AMENDED: 11/01/90 Sufficient numbers of patients will be enrolled from all centers starting at week 8 of participation in the parent study to achieve a total of 240 evaluable patients who will remain in the nested study for a maximum duration of 45 months. Enrollment will continue until all eligible and interested 081 patients are enrolled. Fungal prophylaxis will begin at the time of enrollment into the nested study and will continue until an efficacy or safety end point is reached, until withdrawal from the nested study, or until death. Original design: Patients included are those already enrolled in ACTG 081. Patients are enrolled from all centers at either week 8, 12, 16, 20, 24, 28, or 32 of participation in the parent study. They are randomized to receive either oral fluconazole or clotrimazole troches. Prophylaxis continues until a serious fungal infection develops, the end of the parent study is reached (which is expected to be December 1991), the patient withdraws from either the nested or parent study, or the patient dies. Clinical examination is performed at 2 weeks and then monthly (or more if clinically indicated) for the duration of antifungal prophylaxis; the schedule of evaluation is the same as for the parent study. There is a 1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason.
Eligibility:
Study Type: Interventional, Prevention, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Zidovudine (AZT). - Antipneumocystis prophylaxis. Allowed: - Topical suppressive antifungal agents. Eligibility requirements are: - Participation in NIAID ACTG 081. - No history of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis. - Willingness to sign an informed consent. - Transaminases < 5 x upper limit of normal. - Noncompliance will not be a reason for withdrawal of a patient from the study, unless patient refuses further treatment. Allowed: - A history of oropharyngeal, vaginal or cutaneous candidiasis. - Dermatophyte infections (i.e., tinea pedis) at entry but not active candida infection. Sites of suspected dermatophyte involvement other than the feet should have candida excluded by culture. Prior Medication: Allowed: - Topical suppressive antifungal agents. Exclusion Criteria Co-existing Condition: Patients with the following conditions or diseases are excluded: - History of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis. - Active systemic fungal infection at time of enrollment. - Active superficial fungal infection at time of entry. (Such patients may be treated with topical antifungal agents and may be randomized if they are in clinical remission 14 days after completion of such therapy.) Concurrent Medication: Excluded: - Amphotericin B. - Fluconazole. - Itraconazole. - SCH 39304. - Other systemic antifungals. Patients with the following are excluded: - Previous or currently active systemic fungal infection. - History of allergy or intolerance to imidazole or azoles. - Positive serum cryptococcal antigen titer at any dilution. - Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium infection.
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
BozzetteeS, Study Chair,
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, 089030019
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 981;
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000676
Other Candidiasis Studies:
1. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children with Fever and Neutropenia
2. Voriconazole to Treat Fungal Infections
3. PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
4. Voriconazole to Prevent Systemic Fungal Infections in Children
5. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Related Studies:
Other Candidiasis Clinical Trials
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Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
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