PER-054-05已完成未知
Vicriviroc (SCH 417690) in the Combined Treatment with an Optimized Antiretroviral Regimen in Subjects with Previous Antiretroviral Therapy (Study VICTOR-E1)
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
入选标准
- •1. Subjects must be adults (> 18 years old) of either sex and of any race.
- •2. Subjects must have an HIV infection confirmed by a positive analysis of HIV RNA in plasma prior to Selection.
- •3. In the Selection phase, the HIV strain of each of the subjects should be tropic to R5 only.
- •4. In the opinion of the researcher, the best treatment regimen for the subject should be an optimized ART regimen composed of> 3 drugs, including an IR, reinforced with> 100 mg of ritonavir QD.
- •5. Treatments with a ART regimen> 3 months duration, the HIV RNA levels of the subjects should be> 5000 copies / ml.
- •6. Subjects must have been treated previously for> 3 months with> 3 classes of antiretroviral agents currently marketed.
- •7. The HIV genotype of the subjects should have> 1 mutation of resistance to the nucleoside reverse transcriptase inhibitor / nucleotide class and> 1 primary mutation of resistance to the IP class.
- •8. Subjects must present acceptable hematological, renal and hepatic laboratory values.
- •9. Subjects must be exempt from any disease, condition or clinically relevant situation.
- •10. Women in conditions of procreation should have a negative serum pregnancy test.
- •11. Women in conditions of procreation should agree to use a medically accepted method of contraception.
- •12. Women who are able to procreate who are not having sex should agree to use a medically acceptable method of contraception.
- •13. The subjects must be willing to give their informed consent in writing and able to comply with the schedules of visits and administration of the doses.
排除标准
- •1. Subjects with detectable X4 or R5 / X4 virus.
- •2. Subjects with a history of recurrent seizure disorders of any kind.
- •3. Subjects with an injury or illness of the CNS that predisposes them to having seizures.
- •4. Subjects whose use of any drug represents an increased risk of seizures.
- •5. Chronic addiction to an agent that could increase the risk of seizures when removing said agent in the Selection or during the study.
- •6. Subjects with a serious illness, such as an active opportunistic infection defining AIDS that requires systemic treatment and / or hospitalization in a hospital.
- •7. Subjects with any clinically relevant condition or situation other than the condition being studied.
- •8. Subjects with intercurrent disease, vaccinations or who have used immunomodulators.
- •9. Subjects with allergy / sensitivity to the study drug or its excipients.
- •10. Women who are breastfeeding, pregnant or who intend to become pregnant.
- •11. Subjects who are participating in any other clinical study, unless specifically approved by the project´s physician.
- •12. Subjects who are members or family members of the staff of the team directly involved in this study.
- •13. Subjects who have previously used a CCR5 inhibitor for> 4 weeks and / or within 30 days of the Screening visit.
- •14. Subjects who have received any of the treatments detailed in Table 3.
研究者
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