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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients Clinical research trials and A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients



A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

For Condition: HIV Infections,Histoplasmosis
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - Residence in an area endemic for H. capsulatum. - Absolute CD4 count < 150 cells/mm3. - No current or past active histoplasmosis. - No other active fungal infection. - Life expectancy of at least 1 year. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma. - Inability to take oral medication. Concurrent Medication: Excluded: - Systemically-active antifungals. - Investigational drugs (expanded access drugs are acceptable). - Rifampin. - Rifabutin. - Terfenadine. - Astemizole. - Phenobarbital. - Phenytoin. - Carbamazepine. - H2 blockers. - Omeprazole. - Continual antacids. Patients with the following prior conditions are excluded: History of intolerance to imidazole or azole compounds. Prior Medication: Excluded within 1 month prior to study entry: - Investigational drugs (expanded access drugs are acceptable). Excluded within 15 days prior to study entry: - Rifampin. - Rifabutin. - Terfenadine. - Astemizole. - Phenobarbital. - Phenytoin. - Carbamazepine.
Total Enrollment: 

Location and Contact Information:

Infectious Diseases of Indianapolis
Indianapolis,  Indiana,  46280
United States
 

ASCC
Memphis,  Tennessee,  38103
United States
 

Dr Mark A Pierce
Nashville,  Tennessee,  37232
United States
 

Dr Michael Threikeld
Memphis,  Tennessee,  38105
United States
 

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

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

Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 


Additional Information:
Study ID Numbers:
  235B;  MSG 28,ITR-USA-73
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002438

Other Hiv Infections Studies:
1. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs

2. A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients with AIDS

3. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS

4. Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

5. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

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