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A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS Clinical research trials and A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS clinical trial. Human subjects often obtain the finest healthcare possible for their A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS  A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
For Condition: HIV Infections,Histoplasmosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
Details: Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse. AIDS patients who have been successfully treated with amphotericin B for an acute first episode of disseminated histoplasmosis are selected for treatment. They receive daily oral doses of itraconazole for a total of 52 weeks. Patients who do not experience significant toxicity related to the drug may continue to receive itraconazole until the last patient completes 52 weeks of itraconazole therapy or has the study drug discontinued prior to completing 52 weeks of therapy. AMENDED: Patients will be treated for a minimum of 52 weeks. Patients who complete the 52 weeks and remain on the study drug will continue to be followed. If itraconazole becomes licensed for histoplasmosis, study drug must be discontinued at the end of 52 weeks of therapy or at the time of licensure for patients who have received more than 52 weeks of therapy.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Itraconazole therapy must begin no more than 6 weeks after discontinuing primary amphotericin B therapy; itraconazole therapy may begin immediately after stopping the primary therapy with amphotericin B. Allowed: - Oral contraceptives. - Methadone. - Narcotics. - Acyclovir. - Acetaminophen. - Sulfonamides. - Trimethoprim / sulfamethoxazole. - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis (patients with a total CD4+ count < 200 or a history of PCP should receive PCP prophylaxis). - Treatment IND drugs. - Zidovudine. - Topical antifungals. - Discouraged: - Antacids. - Sucralfate. - H2 blockers. Concurrent Treatment: Allowed: - Radiation therapy for mucocutaneous Kaposi's sarcoma. Prior Medication: Required: - Prior treatment with amphotericin B for disseminated histoplasmosis: - minimum total dose of 15 mg/kg for patients < 67 kg, or 1 g for patients > 67 kg; must have been administered over 6 months or less. Allowed: - Amphotericin B as maintenance therapy for a maximum of 6 weeks following completion of primary therapy. - Zidovudine. - Prophylaxis for Pneumocystis carinii pneumonia. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - History of allergy to, or intolerance of, imidazoles or azoles. - Clinical findings of active histoplasmosis. - Histoplasmosis of the central nervous system. - Inability to take oral medications reliably or severe malabsorption syndrome. - Malignancies requiring cytotoxic therapy. - Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis. Concurrent Medication: Excluded: - Amphotericin B as maintenance therapy. - Immunostimulants. - Ketoconazole. - Systemic antifungals. - Steroids in excess of physiologic replacement doses. - Cytotoxic chemotherapy. - Investigational agents not specifically allowed. - Antacids for 4 hours before and 4 hours after itraconazole. Concurrent Treatment: Excluded: - Lymphocyte replacement. Patients with the following conditions are excluded: - History of allergy to, or intolerance of, imidazoles or azoles. - Clinical findings of active histoplasmosis. - Histoplasmosis of the central nervous system. - Inability to take oral medications reliably or severe malabsorption syndrome. - Malignancies requiring cytotoxic therapy. - Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis. Prior Medication: Excluded within 30 days of study entry: - Immunostimulants. - Ketoconazole. - Systemic antifungals. - Steroids in excess of physiologic replacement doses. - Cytotoxic chemotherapy. Prior Treatment: Excluded: - Lymphocyte replacement. Risk Behavior: Excluded: - Patients who in the opinion of the investigator would be undependable with regard to adherence to protocol. Inclusion criteria are: - HIV infection documented by presence of antibody, by ELISA with Western blot confirmation, or serum p24 antigen, or by recovery of HIV in culture. - Acute first episode of disseminated histoplasmosis documented by recovery and identification of H. capsulatum from cultures obtained from extrapulmonary sites. - Oriented to person, place, and time, and able to give written informed consent.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
LJWheat, Study Chair,
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: ACTG 084;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000992
Other Hiv Infections Studies:
1. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
2. Pharmacokinetics of Intermittent Rifabutin and Isoniazid with Daily Efavirenz
3. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
4. Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
5. Long-Term Effects of HIV Exposure and Infection in Children
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A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
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