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Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs Clinical research trials and Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs clinical trial. Human subjects often get the best healthcare possible for their Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "W" Clinical Trials Conditions > Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs  Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
For Condition: HIV Infections,Histoplasmosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine whether stopping preventive histoplasmosis medications in patients who are currently receiving effective anti-HIV drugs will place them at risk for getting histoplasmosis again. Histoplasmosis is a serious opportunistic (AIDS-related) infection that responds well to antifungal medications. Before anti-HIV drugs, patients with histoplasmosis required lifelong antifungal therapy. Patients who take anti-HIV drugs for a long time may see an improvement in their immune system functions. Improved immune function may eliminate the need for long-term preventive treatment with antifungal agents. Doctors want to see if the improved immune functions allow preventive treatment for histoplasmosis to be stopped. (This study has been changed to include histoplasmosis treatment with drugs other than itraconazole.)
Details: Histoplasmosis is a serious opportunistic infection in persons with AIDS that demonstrates an excellent response to antifungal therapy. However, until the advent of highly active antiretroviral therapy (HAART), patients with histoplasmosis required lifelong suppressive antifungal therapy. It is thought that immune reconstitution as a result of HAART may diminish the need for chronic therapy. Histoplasmosis offers an opportunity to examine the concept of discontinuation of maintenance therapy as it is rapidly diagnosed and effectively treated with itraconazole [AS PER AMENDMENT 9/27/00: or other appropriate therapy for disseminated histoplasmosis] should relapse occur. Patients discontinue antifungal maintenance therapy. Patients are seen for routine visits every 8 weeks and urine and serum specimens are collected for real time Histoplasma antigen testing and immunologic parameters. Patients with suspected recurrence, as determined by clinical or routine laboratory findings consistent with recurrent histoplasmosis, are reevaluated within 1 week of onset of these findings. Patients with suspected recurrence based on a serum or urine Histoplasma antigen rise of 2 units or more, in the absence of clinical or routine laboratory findings consistent with histoplasmosis, are reevaluated within 2 weeks. All patients with suspected recurrence have more frequent evaluations and additional laboratory tests. Those with negative studies resume bimonthly follow-up. All patients who develop proven (positive culture or positive fungal stain of tissues or body fluids) or probable relapse (clinical findings of relapse with an increase in antigen of 4.1 units or more, or no clinical findings but increases in antigen levels on repeated testing with the most recent antigen test demonstrating an increase in antigen of 4.1 units or more) or who experience persistent reduction of CD4 cell count to below 100/mm3 have antifungal induction therapy reinstituted. Patients remain on study for at least 12 months with regular follow-up/evaluations.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 13 years or older. - Have consent of parent or guardian if under 18 years of age. - Have HIV infection. - Have 2 CD4 cell counts above 150 cells/mm3 (1 of which has been obtained within 6 months and the other within 30 days before entry). Note: The 2 CD4 counts used for eligibility must be from tests performed at least 1 week apart. - Have received at least 1 year of treatment for histoplasmosis. (This study has been changed to include patients who have received histoplasmosis treatment with drugs other than itraconazole.) - Are receiving treatment for histoplasmosis or have stopped treatment within 24 weeks of study entry. - Have had histoplasmosis before but are free of any signs of histoplasmosis at entry into the study. - Have a negative pregnancy test within 14 days of study entry. - Have been on anti-HIV drugs for at least 24 successive weeks and have been on a stable anti-HIV drug combination for at least 8 weeks before entry. Exclusion Criteria Patients will not be eligible for this study if they: - Have any recurrence of histoplasmosis within 4 weeks of study entry. - Have received medications that affect the immune system including chemotherapy or corticosteroids within the last 2 months. (This study has been changed. Patients taking IL-2 are no longer excluded.) - Have a systemic infection. Patients on stable preventive treatment for certain opportunistic (AIDS-related) infections for at least 3 months will be eligible. - Require treatment for fungal infections with systemic antifungal medications. - Have meningitis or brain or spinal cord damage thought to be caused by Histoplasma infection.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
MitchGoldman, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
University of California San Francisco
San Francisco, California, 941104206
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Additional Information:
Study ID Numbers: ACTG A5038; AACTG A5038
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006316
Other Histoplasmosis Studies:
1. A Study of 141W94 Used Alone or in Combination with Zidovudine Plus 3TC in HIV-Infected Patients
2. A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
3. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
4. Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
5. A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
Related Studies:
Other Histoplasmosis Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
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