Megestrol Acetate For Failure To Thrive In Pediatric HIV

Gamma Project - ACTU2 个研究点分布在 1 个国家目标入组 25 人开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).

The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

•Patients must have:
•Documented HIV infection.
•Failure to thrive as defined by:
•crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
•Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
•Free of significant acute illness (mild upper respiratory tract infections allowed).
•Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out.

•Co-existing Condition:
•Patients with the following symptoms are excluded:
•Gastrointestinal infection or malabsorption.
•Significant acute illness.
•Any identified, untreated cause for failure to thrive other than underlying HIV infection.
•Medical contraindications to megestrol acetate.
•Patients with any of the following prior conditions or symptoms are excluded:
•Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.
•History of prior megestrol acetate therapy in the past six months.

发起方

Gamma Project - ACTU

申办方类型

Other

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