Showing papers by "AIDS Clinical Trials Group published in 1997"
Indiana University – Purdue University Indianapolis1, AIDS Clinical Trials Group2, National Institutes of Health3, University of Cincinnati4, University of Texas Health Science Center at Houston5, Baylor College of Medicine6, University of Missouri–Kansas City7, University of Alabama at Birmingham8, San Francisco General Hospital9, Ohio State University10, Cornell University11, University of Southern California12, Icahn School of Medicine at Mount Sinai13, Tulane University14, Veterans Health Administration15, Washington University in St. Louis16
TL;DR: Fluconazole 800 mg daily is a safe and moderately effective induction therapy for mild or moderately severe disseminated histoplasmosis in patients with AIDS.
133 citations
University of California, San Francisco1, Yeshiva University2, United States Department of Veterans Affairs3, Indiana University – Purdue University Indianapolis4, AIDS Clinical Trials Group5, National Institutes of Health6, University of Cincinnati7, University of Southern California8, University of Minnesota9, University of Rochester10, Tulane University11, University of Massachusetts Medical School12, Icahn School of Medicine at Mount Sinai13, Cornell University14, Duke University15
TL;DR: Itraconazole, 200 mg daily, is effective in preventing relapse of disseminated histoplasmosis in patients with AIDS, but clinicians should be alert for drug interactions and possible hepatotoxicity.
Abstract: PURPOSE To study the efficacy and safety of maintenance treatment with itraconazole for disseminated histoplasmosis in patients with AIDS. PATIENTS AND METHODS This was a prospective, multicenter, open-label study conducted at university-based hospitals participating in the AIDS Clinical Trial Group (ACTG). Forty-six AIDS patients with mild to moderate disseminated histoplasmosis who had successfully completed 12 weeks of induction treatment with itraconazole were treated with itraconazole, 200 mg once daily (42 patients) or 400 mg once daily (4 patients). Patients were followed at monthly intervals with clinical and laboratory assessment for relapse or toxicity. Primary outcome measures were relapse of histoplasmosis and survival. Secondary outcome measures included drug-limiting toxicity and changes in serum and urine Histoplasma polysaccharide antigen (HPA) levels. RESULTS Two patients relapsed during a median follow-up period of 87 weeks. The 1-year relapse-free rate was estimated to be 95.3% (95% CI, 85.3%-99.7%). One relapse may have been related to poor adherence to treatment and the second to concurrent administration of rifampin. From the start of maintenance treatment, the estimated 1-year survival rate was 73.0% (95% CI, 67.5%-77.9%). Five patients discontinued treatment because of suspected drug toxicity, three of whom had possible or probable hepatotoxicity. Median serum and urine HPA levels declined significantly during treatment. The only patient in whom antigen levels rose >2 U developed clinical relapse 1 week later; antigen levels were unavailable in the other relapsing patient. CONCLUSIONS Itraconazole, 200 mg daily, is effective in preventing relapse of disseminated histoplasmosis in patients with AIDS. It is generally well tolerated, but clinicians should be alert for drug interactions and possible hepatotoxicity.
59 citations