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Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial.
J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 01; 16(2):100-7.JA

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.

Authors+Show Affiliations

Albert Einstein College, Bronx, New York, U.S.A.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

9358104

Citation

Hecht, F M., et al. "Itraconazole Maintenance Treatment for Histoplasmosis in AIDS: a Prospective, Multicenter Trial." Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association, vol. 16, no. 2, 1997, pp. 100-7.
Hecht FM, Wheat J, Korzun AH, et al. Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1997;16(2):100-7.
Hecht, F. M., Wheat, J., Korzun, A. H., Hafner, R., Skahan, K. J., Larsen, R., Limjoco, M. T., Simpson, M., Schneider, D., Keefer, M. C., Clark, R., Lai, K. K., Jacobson, J. M., Squires, K., Bartlett, J. A., & Powderly, W. (1997). Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association, 16(2), 100-7.
Hecht FM, et al. Itraconazole Maintenance Treatment for Histoplasmosis in AIDS: a Prospective, Multicenter Trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 1;16(2):100-7. PubMed PMID: 9358104.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. AU - Hecht,F M, AU - Wheat,J, AU - Korzun,A H, AU - Hafner,R, AU - Skahan,K J, AU - Larsen,R, AU - Limjoco,M T, AU - Simpson,M, AU - Schneider,D, AU - Keefer,M C, AU - Clark,R, AU - Lai,K K, AU - Jacobson,J M, AU - Squires,K, AU - Bartlett,J A, AU - Powderly,W, PY - 1997/11/14/pubmed PY - 1997/11/14/medline PY - 1997/11/14/entrez SP - 100 EP - 7 JF - Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association JO - J Acquir Immune Defic Syndr Hum Retrovirol VL - 16 IS - 2 N2 - 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. SN - 1077-9450 UR - https://www.unboundmedicine.com/medline/citation/9358104/Itraconazole_maintenance_treatment_for_histoplasmosis_in_AIDS:_a_prospective_multicenter_trial_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=9358104.ui DB - PRIME DP - Unbound Medicine ER -