EUCTR2009-015904-24-DE进行中（未招募）不适用
An open, prospective study to compare the safety and efficacy of raltegravir vs. atazanavir / ritonavir, both in combination with tenofovir DF and emtricitabine, in the treatment of HIV-infection in ART naive subjects with HCV co-infection - not available
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- HIV and Hepatitis C co-infected patients
- •- indication for HAART according to current German-Austrian guidelines
- •- HAART naive
- •- no primary NRTI / Integrase / PI associated resistance mutation according to the Stanford algorithm at screening; every patient MUST have a genotypic resistance assay prior baseline available (< 6 months prior to baseline)
- •- women of childbearing age: negative pregnancy test
- •- ability to sign written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- advanced liver cirrhosis Child-Pugh B or C or decompensated liver disease
- •- pegylated interferon / ribavirin or other anti-HCV therapy; planned anti-HCV therapy for duration of the study (48 weeks).
- •- acute or chronic hepatitis B infection
- •- acute hepatitis A or other hepatotropic virus infections
- •- any other chronic liver disease such as alcohol abuse or hemosiderosis
- •- use or planned use (for the duration of the study, 48 weeks) of rifampicin, St. John´s wort and drugs that are metabolizd via the cytochrome P450 system with a narrow therapeutic PK-range such as astemizole, terfenadine, cisapride, pimozide, chinidine, bepridile, triazolam, midazolam, ergotamine, dihydroergotamine, ergometrine, methyl-ergomethrine. FOR OTHER COMEDICATIONS please consult with the SPC of Raltegravir (Isentress®), Atazanavir (Reyataz®), Ritonavir (Norvir®), your hospital pharmacist, www.hiv-drug-interactions.org or the principal investigator in case of uncertainty.
- •- new AIDS defining event, except for Kaposi sarcoma, < 1 months prior to screening
- •- malignancy, except for Kaposi sarcoma, with current radio- or chemotherapy
- •-history of organ transplantation
- •- ALT = 5 fold the upper limit of norm
- •- creatinine clearance < 70 ml / min according to Cockcroft-Gault
- •- serum phosphate < 2.0 mg/dl
- •- chronic kidney disease
- •- diabetes mellitus
- •- active use of illicit drugs
- •- pregnancy, brest-feeding (not recommended for HIV-infected mothers because of risk of HIV transmission to the new-born)
- •- any medical condition that in the view of the investigator is not suitable for participation in a clinical trial
- •-participation in another clinical trial
研究者
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