PER-094-11未知未知
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CLINICAL TRAIL TO COMPARE THE SAFETY AND EFFICACY OF REDUCED DOSE EFAVIRENZ (EFV) WITH STANDARD DOSE EFV PLUS TWO NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (N(T)RTI) IN ANTIRETROVIRAL -NAIVE HIV-INFECTED INDIVIDUAL OVER 96 WEEKS
The Kirby Institute for infection and inmmunity in Society,0 个研究点目标入组 0 人开始时间: 2012年1月16日最近更新:
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 79（—）
- 性别
- All
入选标准
- •HIV-1 POSITIVE AS FOR AUTHORIZED DIAGNOSTIC TEST.
- •OVER 16 YEARS (OR MINIMUM AGE DETERMINED BY LOCAL RULES OR BE AUDITED BY LOCAL REQUIREMENTS).
- •50 • ≥ 1000 HIV RNA copies/ml
- •PRE-TREATMENT WITHOUT ART EXHIBITION (INCLUDING TREATMENTS ANTIRETROVIRALS CLIPPED TO PREVENT VERTICAL TRANSMISSION OR MTCT)
- •CALCULATED CREATININE CLEARANCE (CrCl) ≥ 50 mL/min (Cockcroft-GAULT).
- •DELIVERY OF INFORMED CONSENT IN WRITING.
排除标准
- •LABORATORY VALUES FOLLOWING:
- •ABSOLUTE NEUTROPHIL COUNT (ANC) <500 cells / µl
- •HEMOGLOBIN <7.0 g / dL
- •PLATELET COUNT <50,000 cells/µl
- •AST AND/OR ALT> 5 x ULN
- •PREGNANT OR NURSING MOTHERS
- •OPPORTUNISTIC OR MALIGNANT DISEASES THAT ARE NOT ON ACTIVE CONTROL RIGHT
- •IMMUNOMODULATING USE WITHIN 30 DAYS PRIOR TO THE VISIT OF SELECTION
- •ANY MEDICATION USE PROHIBITED
- •CURRENT CONSUMPTION OF ALCOHOL OR OTHER ILLEGAL SUBSTANCE THAT MAY ADVERSELY AFFECT PARTICIPATION IN THE STUDY.
研究者
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