CTRI/2012/10/003035进行中（未招募）3 期
Multicenter Study of Options for SEcond-Line Effective Combination Therapy (SELECT)
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA0 个研究点目标入组 600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
入选标准
- •Inclusion Criteria
- •HIV 1 infected
- •Confirmation of first line virologic failure
- •Certain laboratory values obtained within 45 days prior to study entry More information on this criterion can be found in the study protocol
- •Negative pregnancy test within 48 hours prior to study entry
- •Must refrain from participating in a conception process and if participating in sexual activity that could lead to pregnancy must use at least one acceptable type of contraceptive More information on this criterion can be found in the study protocol
- •Ability and willingness of participant or legal guardian representative to provide informed consent
排除标准
- •Exclusion Criteria:
- •Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days prior to study entry, with the exception of a tapering course of corticosteroids as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic obstructive pulmonary disease flare and/or prednisone at a daily dose of <10 mg (physiologic replacement dose).
- •If the potential participant has had resistance testing, evidence of broad NRTI cross-resistance that, in the opinion of the investigator, would not allow selection of an effective NRTI combination if the participant were randomized to the LPV/r + best available NRTIs arm.
- •Prior exposure to a Protease Inhibitor.
- •Known history of congenital long QT syndrome, hypokalemia, or planned use of other drugs that prolong the QT interval.
- •Pregnancy or breast-feeding.
- •Known history of chronic hepatitis B virus (HBV) infection or current HBV infection defined by the presence of hepatitis B surface antigen in serum or plasma.
- •Active tuberculosis (TB) requiring treatment with rifampicin.
- •Previously diagnosed malignancies other than basal cell carcinoma and cutaneous Kaposi sarcoma.
- •Requirement for taking any medications that are prohibited with the study drugs. More information on this criterion can be found in the study protocol, section 5.4.
- •Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
- •Active drug or alcohol use or dependence or other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.
研究者
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