NL-OMON35121已完成不适用
The Effect of Rosuvastatin on Immune Activation Markers in Treatment-naïve HIV-Positive Patients; a Randomized Placebo-Controlled Trial - StatHiv trial
Onze Lieve Vrouwe Gasthuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 99（—）
入选标准
- •Adults 18 years of age or older.
- •HIV-1 infection, as documented by a licensed ELISA test kit and confirmed by a Western blot assay
- •No evidence of acute HIV infection. For the purposes of this study acute HIV infection will be defined as presence of a detectable HIV-1 viral RNA in the presence of a non reactive HIV-1 or HIV-2 antibody assay or an indeterminate western blot.
- •Treatment naïve, i.e. no current of previous use of HAART
- •Willingness to use a method of contraception during the study period. Adequate methods of birth control include: condoms, male or female, with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; any of the methods that require a prescription (such as contraceptive pills or patch, Norplant, Depo-Provera, and others) or a male partner who has previously undergone a vasectomy.
- •Willingness to have blood drawn.
- •Non known allergy or contraindication to rosuvastatin use.
- •Ability to understand and willingness to sign the informed consent.
- •Willingness to have blood stored for future phenotyping and genotyping.
- •CD4 cell count greater than 350 cells/ml.
- •Two viral loads that average greater than 1000 copies/ml within a 4 week period.
- •Liver function tests (AST or ALT) not greater than 1.5 times the upper limit of normal. Evidence of active hepatitis B or C will not be considered an exclusion criterion if the liver function tests are within normal limits.
- •Creatine phosphokinase elevations (CK) not greater than 3 times the upper limit of normal (ULN) on two sequential determinations and, in the opinion of the investigator, without clear association with exercise.
- •Laboratory values:
- •Absolute neutrophil count (ANC) greater than or equal to 1000/mm3.
- •Hemoglobin greater than or equal to 7.5 mmol/L
- •Platelet count greater than or equal to 100,000/mm3
- •Creatinine less than or equal to 2 x ULN.
- •Serum amylase and lipase less than or equal to 1.25 x ULN.
- •Negative serum pregnancy test at randomization.
排除标准
- •Pregnancy or breast feeding.
- •Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study.
- •Serious illness requiring systemic treatment and/or hospitalization within 30 days of entry.
- •Evidence of active opportunistic infections or neoplasms that require chemotherapy during the study period
- •Allergy or hypersensitivity to rosuvastatin or any of its components.
- •History of myositis or rhabdomyolysis with use of any statins.
- •History of inflammatory muscle disease such as poly- or dermatomyositis.
- •Concomitant use of fibric acid derivatives or other lipid lowering agents including statins and ezetimibe.
- •Concomitant use of drugs that have significant interactions with rosuvastatin. .
- •Concomitant use of St.Johns wort.
- •Concomitant use of Valproic acid.
- •Patients who are on concurrent immunomodulatory agents
- •Serum LDL cholesterol less than 1.0 mmol/L.
- •Vaccinations within 6 weeks of study entry.
研究者
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