PER-039-07已完成未知
A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis With CD4 Less Than 250 Cells/mm3
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 0 至 0（—）
入选标准
- •1. HIV-1 infection.
- •2. TB confirmed or probable.
- •3. X-ray of the chest within 30 days prior to study entry.
- •4. Current TB treatment based on rifampicin and other rifamycin derivatives initiated within 14 days prior to admission to the study.
- •5. Amount of CD4 cells <200 cells / mm3 obtained within 30 days before admission to the study in any of the laboratories approved by DAIDS.
- •6. The following laboratory values obtained within 14 days prior to admission to the study: a) Absolute number of neutrophils ≥ 500 cells / mm3. b) Hemoglobin ≥ 7.0 g / dL. c) Amount of platelets ≥ 50,000 / mm3. d) Estimated creatinine clearance ≥ 60 mL / min. e) AST (SGOT), ALT (SGPT), bilirubin, and alkaline phosphatase ≤ 5 x ULN.
- •7. Female participants with reproductive potential with a serum or negative urine pregnancy test within 7 days before admission to the study.
- •8. All participants must agree to avoid any conception process.
- •9. Female participants who are participating in a sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception.
- •10. Ability to swallow medications orally.
- •11. Male and female participants, aged ≥ 13 years.
- •12 The ability and availability of the participant or the tutor / representative to give informed consent.
排除标准
- •1. Having received at any time prior to admission to the study for> 7 days of cumulative treatment with any ARV or treatment during any period of time with 2 or more ARVs in combination.
- •2. Breastfeeding.
- •3. Allergy / sensitivity to any study drug or its formulations.
- •4. Having a prior history of documented multidrug resistant TB.
- •5. Having received any research or chemotherapy therapy within 30 days prior to admission to the study.
- •6. Anticipated reception of any of the prohibited medications.
研究者
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