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A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Clinical research trials and A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis clinical trial. Test subjects typically receive the most effective healthcare possible for their A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

Home > "A" Clinical Trials Conditions > A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis



A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
Details: At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored. Patients are selected by a randomization process to take amphotericin B intravenously (in the vein), for 14 days, and either placebo (ineffective substance) or flucytosine for 14 days. Then patients are again selected by a randomization process to take either (1) fluconazole for a total of 8 weeks plus itraconazole placebo; or (2) itraconazole for a total of 8 weeks plus fluconazole placebo.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Interruption of myelosuppressive therapies and/or administration of erythropoietin, at discretion of investigator, to maintain hemoglobin = or > 7 g/dl. - Adjunctive corticosteroids may be administered during the triazole phase for patients who develop Pneumocystis carinii pneumonia and meet the prescribed criteria. - Hydrocortisone, not to exceed 50 mg/day, during the amphotericin phase. - Aerosolized pentamidine or systemic chemoprophylaxis for Pneumocystis carinii pneumonia should be given to all patients with a CD4 count < 200 cells/mm3. - Antiretroviral drugs (including zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC)) after patient has tolerated oral triazole for one week (after 3 weeks of study treatment). - Maintenance treatment (except for rifamycins) for other opportunistic infections such as cytomegalovirus (CMV) retinitis, cerebral toxoplasmosis or mycobacterial infections, provided that their hematologic and hepatic values are stable and they meet the entry criteria. Concurrent Treatment: Allowed: Transfusion, at discretion of investigator, to maintain hemoglobin = or > 7 g/dl. Patients must have: - HIV infection. - Primary episode of acute cryptococcal meningitis. - Willing to participate in the study for a full 10 weeks and either be able to give informed consent or have a family member or guardian able to give informed consent. Prior Medication: Allowed: Fluconazole prophylaxis, not exceeding 200 mg/day. Risk Behavior: Allowed: History of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers) and their sexual partners. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Inability to take oral medication (if necessary, flucytosine and flucytosine placebo may be administered via nasogastric tube during the amphotericin phase). - History of hypersensitivity to imidazole or triazole compounds. - Active hepatitis (viral, drug-induced, or other) defined by progressive worsening of hepatic enzymes to grade 3 or 4 toxicity on at least two occasions. - Comatose. - Concurrent CNS disease which, in the opinion of the investigator, would interfere with assessment of response. Concurrent Medication: Excluded: - Continued treatment with H2 blockers (ranitidine (Zantac), cimetidine (Tagamet), omeprazole (Prilosec), nizatidine (Axid), famotidine (Pepcid)). - Antacids and didanosine (ddI) within 2 hours of triazole administration. - Rifampin, rifabutin (Ansamycin), and other rifamycin derivatives, phenytoin (Dilantin), phenobarbital, or carbamazepine (Tegretol). - Other systemic antifungal agents. Prior Medication: Excluded: - Amphotericin, > 1 mg/kg, or fluconazole or ketoconazole, > 1200 mg, as prior treatment for current primary episode of acute cryptococcal meningitis or treatment started for this episode more than 72 hours prior to enrollment into study. - Phenytoin (Dilantin), carbamazepine (Tegretol), phenobarbital, rifabutin (Ansamycin), rifampin or other rifamycins within the last 15 days. Patients may not have: - Inability to take oral medication (if necessary, flucytosine and flucytosine placebo may be administered via nasogastric tube during the amphotericin phase). - History of hypersensitivity to imidazole or triazole compounds. - Active hepatitis. - Patients who are comatose. - Concurrent CNS disease which, in the opinion of the investigator, would interfere with assessment of response.
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
vanHorst C,  Study Chair, 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Med Univ of South Carolina / UNC
Charleston,  South Carolina,  29425
United States
 

Univ of Mississippi Med Ctr
Jackson,  Mississippi,  39216
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Saint Michael's Med Ctr
Newark,  New Jersey,  07102
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Audie L Murphy Veterans Administration Hosp
San Antonio,  Texas,  78284
United States
 

Montefiore Med Ctr Adolescent AIDS Program
Bronx,  New York,  10467
United States
 

Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Med College of Georgia
Augusta,  Georgia,  30912
United States
 

Tulane Univ School of Medicine
New Orleans,  Louisiana,  70112
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Bronx Veterans Administration / Mount Sinai Hosp
Bronx,  New York,  10468
United States
 

Houston Med Ctr
Houston,  Texas,  77030
United States
 

Cornell Univ Med Ctr
New York City,  New York,  10021
United States
 

Dr Thomas M Kerkering
Richmond,  Virginia,  23298
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

SUNY - Stony Brook
Stony Brook,  New York,  117948153
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

North Central Bronx Hosp / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Ann Arbor Veterans Administration Med Ctr
Ann Arbor,  Michigan,  48105
United States
 

Univ of Missouri at Kansas City School of Medicine
Kansas City,  Missouri,  64108
United States
 

Johns Hopkins Univ School of Medicine
Baltimore,  Maryland,  21205
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Yale Univ / New Haven
New Haven,  Connecticut,  065102483
United States
 

Univ of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

Nassau County Med Ctr
East Meadow,  New York,  11554
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Univ of Massachusetts Med Ctr
Worcester,  Massachusetts,  01655
United States
 

Dr Jack D Sobel
Detroit,  Michigan,  48201
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

George Washington Univ Med Ctr
Washington D.C.,  District of Columbia,  20037
United States
 

Infectious Diseases Association / Research Med Ctr
Kansas City,  Missouri,  64132
United States
 

Samaritan Village Inc / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10025
United States
 

Houston Veterans Administration Med Ctr
Houston,  Texas,  77030
United States
 

Charity Hosp / Tulane Univ Med School
New Orleans,  Louisiana,  70112
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Pennsylvania Hosp
Philadelphia,  Pennsylvania,  19107
United States
 

Moses H Cone Memorial Hosp
Greensboro,  North Carolina,  27401
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Louisiana State Univ Med Ctr / Tulane Med School
New Orleans,  Louisiana,  70112
United States
 

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Emory Univ School of Medicine
Atlanta,  Georgia,  30303
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

San Francisco Veterans Administration Med Ctr
San Francisco,  California,  94121
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Dr Mark A Pierce
Nashville,  Tennessee,  37232
United States
 


Additional Information:
Study ID Numbers:
  ACTG 159;  FDA 235A,MSG Study 17
Study Start Date: 
Record last reviewed: September 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000639

Other Meningitis, Cryptococcal Studies:
1. A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

2. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

3. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

4. A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

5. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis

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Other Meningitis, Cryptococcal Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

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