Withdrawal of Antifungal Treatment for Histoplasmosis in Patients After Improved Immune Response to Anti-HIV Drugs

Completed

Conditions studied: HIV Infections, Histoplasmosis

In brief

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.)

Key facts

Study ID: NCT00006316
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 50
Last updated by the study team: 2008-08-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
University of California San Francisco — San Francisco, California, United States
Emory Univ — Atlanta, Georgia, United States
Cook County Hosp — Chicago, Illinois, United States
Indiana Univ Hosp — Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
Wishard Hosp — Indianapolis, Indiana, United States
Univ of Nebraska Med Ctr — Omaha, Nebraska, United States
Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
Univ of Cincinnati — Cincinnati, Ohio, United States
Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
Julio Arroyo — West Columbia, South Carolina, United States
Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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