OBJECTIVES: I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.

Condition	Treatment or Intervention	Phase
Sickle Cell Anemia	Drug: clotrimazole  Drug: hydroxyurea	Phase I Phase II

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months. Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis

Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day

--Prior/Concurrent Therapy--

Chemotherapy:

• No other concurrent antisickling agent

Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole

--Patient Characteristics--

Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL

Hepatic: AST/ALT no greater than 100 units/L

Renal: Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior adverse reaction to hydroxyurea or clotrimazole
• No recent or progressive neurologic dysfunction

North Carolina
      University of North Carolina School of Medicine, Chapel Hill,  North Carolina,  27599-7070,  United States; Recruiting

Study chairs or principal investigators

Eugene Paul Orringer,  Study Chair,  University of North Carolina   

Study ID Numbers:  199/14273; UNCCH-FDR001531
Record last reviewed:  January 2001
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004492
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09