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Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome 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 Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome Clinical research trials and Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome 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 Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome 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 Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome 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 > "P" Clinical Trials Conditions > Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome  Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
For Condition: HIV Infections,Histoplasmosis
Status: Completed
Sponsor(s): Pfizer , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
Details: Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients. At least 40 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for the study. Patients receive fluconazole for a total of 12 weeks. Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible. Patients are evaluated at weeks 0, 1, 2, 4, 8, and 12. Patients who are doing well without evidence of clinical failure or dose-limiting toxicity are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months; those who relapse on the reduced dose are permitted to receive re-induction with a higher dose.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Corticosteroids for up to 21 days at doses no greater than 20 mg/day prednisone (higher doses may be given for shorter durations, if clinically indicated). - Zidovudine, oral contraceptives, methadone, narcotics, acyclovir, acetaminophen, sulfonamides, trimethoprim/sulfamethoxazole, pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis, topical antifungals, pyrimethamine, ganciclovir. - Didanosine (ddI), dideoxycytidine (ddC), foscarnet, or other investigational drugs considered to be essential for patient management. Concurrent Treatment: Allowed: - Transfusion. Patients must have the following: - HIV infection. - Histoplasmosis. - Appropriate consent must be obtained from a parent or legal guardian for patients less than 18 years of age. Allowed: - Hematologic and/or renal laboratory abnormalities. - Concurrent malignancies. - Concurrent infection with Mycobacteria. - Patients with severe manifestations of histoplasmosis who are thought to be at risk of dying within one week should receive up to 250 mg amphotericin B for up to seven days prior to enrollment and then be re-evaluated. Patients who are still severely ill and do not meet eligibility criteria may not enter the study. Specific criteria defining life-threatening histoplasmosis include: - Systolic blood pressure < 90 mm Hg without other cause; arterial pO2 < 60 torr without other cause; and SGOT > 10 x upper limit of normal or bilirubin > 3 x upper limit of normal. Any other cases not meeting this definition must be reviewed with the protocol chair. Prior Medication: Allowed: - Amphotericin B (up to 250 mg) over 7 days in patients with severe histoplasmosis. Risk Behavior: Allowed: - Patients with a history of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers, recipients of blood or blood products prior to May 1985, or sexual partners of any of the foregoing). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Allergy to, or intolerance of, imidazoles or azoles. - Active hepatitis (viral, drug induced, or other). - Fungal infections for which the study drug is not indicated (e.g., aspergillosis, mucormycosis). - CNS/CSF culture positive for pathogens other than H. capsulatum. If C. neoformans is subsequently identified and the patient is improving, the patient may be allowed to remain on study with the permission of the protocol chair. Concurrent Medication: Excluded: - Corticosteroid use for > 21 days at > 20 mg/day of prednisone. - Systemic antifungals. Prior Medication: Excluded: - Amphotericin B at > 2.5 mg/kg for the current episode of histoplasmosis within 7 days prior to enrollment. - Suppressive treatment for histoplasmosis or other fungal infections with > 200 mg/day of ketoconazole, fluconazole, or itraconazole, or more than 50 mg amphotericin B twice weekly. Risk Behavior: Excluded: - Patients who the investigator feels would be undependable with regard to adherence to the protocol. Patients may not have the following prior conditions: - History of allergy to, or intolerance of, imidazoles or azoles.
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
WheatLJ, Study Chair,
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 641082792
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, 64132
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Additional Information:
Study ID Numbers: ACTG 174; R-0245
Study Start Date:
Record last reviewed: March 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000627
Other Hiv Infections Studies:
1. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
2. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
3. Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
4. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
5. Submacular Surgery Trials (SST)
Related Studies:
Other HIV Infections Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
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