ISRCTN30019040已完成不适用
Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation and viral replication in asymptomatic human immunodeficiency virus (HIV)-infected patients: a phase II, multicentre, randomised, double-blind, placebo-controlled clinical trial
Medical Research Council Clinical Trials Unit (MRC CTU) (UK)0 个研究点目标入组 90 人开始时间: 2007年10月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- 性别
- All
入选标准
- •Current information as of 11/02/2009 (amended in protocol and approved by ethics on 13/10/2008):
- •1. Documented HIV infection on Enzyme-Linked Immuno-Sorbent Assay (ELISA) and confirmatory test
- •2. Age 18 to 65 years, either sex
- •3. Naïve to antiretroviral therapy (ART) or off ART for at least 12 months prior to study entry
- •4. CD4 T-cell count greater than 400 cells/µL on screening blood test and on one other test performed within the 3 months prior to screening
- •5. Plasma HIV RNA viral load greater than 5000 copies/ml on screening blood test
- •6. Willing and able to provide written informed consent
- •Current information as of 29/04/2008:
- •1. Documented HIV infection on Enzyme-Linked Immuno-Sorbent Assay (ELISA) and confirmatory test
- •2. Age 18 to 65 years, either sex
- •3. Naive to antiretroviral therapy (ART) (patients who have taken less than a total of 3 months ART in the past will be eligible, provided that they have been off ART for 1 year prior to study entry)
- •4. CD4 T-cell count greater than 400 cells/µL on screening blood test and on one other test performed within the 3 months prior to screening
- •5. Plasma HIV RNA viral load greater than 5000 copies/ml on screening blood test
- •6. Willing and able to provide written informed consent
- •Initial information at time of registration:
- •1. Male or female patients with documented HIV infection on Enzyme-Linked Immuno-Sorbent Assay (ELISA) and confirmatory test
- •2. Age 18 to 60 years
- •3. Naive to antiretroviral therapy
- •4. CD4 T-cell count greater than 400 cells/µL on screening blood test and on one other test performed within three months prior to screening
- •5. Plasma viral load greater than 5000 copies/ml on screening blood test
- •6. Willing and able to provide written informed consent
- •7. Women of childbearing age must be willing to use contraception during the study and for a period of three months afterwards
- •8. Written informed consent
排除标准
- •Current information as of 11/02/2009 (amended in protocol and approved by ethics on 13/10/2008):
- •1. History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, glucose 6-phosphate dehydrogenase (G6PD) deficiency
- •2. Insulin-dependent or non-insulin-dependent diabetes mellitus
- •3. Chronic liver disease of any cause or alcoholism
- •4. Primary HIV infection within 12 months prior to screening, either confirmed (previous negative HIV antibody test within 12 months), or suspected (symptoms strongly suggestive of HIV seroconversion illness within the previous 12 months and patient not known to be HIV antibody positive prior to the illness)
- •5. Pneumonia, meningitis, septicaemia or any other serious infection in the 2 months prior to screening
- •6. Any acute infection with fever and systemic symptoms within the last 24 hours
- •7. Any vaccinations in the 2 months prior to screening
- •8. Active malignancy (patients are eligible if treatment for the malignancy was completed more than 2 years prior to screening and there has been no subsequent clinical evidence of active disease) or any active immune-mediated or inflammatory disease
- •9. Any known suicide attempts (at any time in the past) or current or past history of depression requiring treatment within the 2 years prior to screening. Patients who have not had depression in the previous 2 years but who have had depression in the past may be included if, in the opinion of the physician, the nature of the past episode of depression and the patient?s current psychological state indicate that the risk of recurrence of depression during the trial is likely to be low. Patients who have received anti-depressant medication for reasons other than symptomatic depression can be included in the trial.
- •10. A woman who is currently pregnant or breastfeeding
- •11. A woman of child-bearing potential who is planning to become pregnant during the course of the study, or is unwilling to take adequate contraception (including barrier contraception) throughout the course of the study
- •12. Use of systemic corticosteroids or other immunomodulatory drugs within the 12 months prior to screening
- •13. Current use of medication with known serious hepatotoxic effects or known interaction with hydroxychloroquine
- •14. Evidence of cardiac conduction defects or cardiac arrhythmia on screening electrocardiogram (ECG)
- •15. Retinopathy or visual field changes detected on screening eye examination
- •16. Hepatitis B surface antigen (HBsAg) positive or Hepatitis C PCR positive (patients who are Hepatitis C antibody positive are allowed to participate provided that PCR is negative)
- •17. Any of the following laboratory abnormalities on screening blood test:
- •17.1. Haemoglobin less than 10.5 g/dl
- •17.2. Absolute neutrophil count less than 1.0 x 10^9/L
- •17.3. Platelet count less than 100 x 10^9/L
- •17.4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or alkaline phosphatase above 2.5 x upper limit of normal (ULN)
- •17.5. Serum creatinine greater than 1.5 x upper limit of normal (ULN)
- •17.6. Estimated creatinine clearance (Cockroft-Gault equation) below 60 ml/min
- •18. Inability to attend or comply with treatment or follow-up scheduling
- •19. Current participation in any other clinical intervention trial
- •Current information as of 29/04/2008:
- •1. History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, glucose 6-phosphate deh
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