ORAL ISOTRETINOIN VERSUS OBSERVATION FOR LOW GRADE CERVICAL DYSPLASIA

$21,006M01FY2000RRNIH

New York University School Of Medicine, New York NY

Investigators

Linked publications & trials

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Abstract

This randomized controlled Phase III trial is being conducted in HIV-infected women who have been diagnosed with low grade cervical dysplasia, stratified according to CD4 counts. Arm 1 will receive oral isotretinoin, 0.5 mg/kg/day for 6 months with follow-up for 12 months. Arm 2 will receive observation only with follow-up for 12 months. The primary objective is to determine the efficacy of isotretinoin for the prevention of progression of mild dysplasia to more severe dysplasia or invasive carcinoma of the cervix. Secondary objectives are to assess the toxicity and efficacy of isotretinoin. Tertiary objectives are to correlate CD4 and CD8 counts with time to progression and to document differences between progression and regression of subjects who are being treated for primary vs. recurrent dysplasia.

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