NL-OMON50727已完成不适用
RAs United as a Novel Anti-HIV strategy (LUNA): a randomized controlled trial. - LUNA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
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
- •1. HIV-1 infected patients *18 years.
- •2. WHO performance status 0 or 1.
- •3. Confirmed HIV-1 infection by 4th generation ELISA, Western Blot or PCR.
- •4. Wild type HIV infection or polymorphisms associated with at highest
- •low-level resistance to any class of ART according to Stanford HIV drug
- •resistance database. Transmitted mutations and acquired mutations due to
- •virological failure associated with resistance of at highest low-level
- •resistance are allowed.
- •5. On cART.
- •6. Current plasma HIV-RNA <50 copies/mL for at least 365 days and measured on
- •at least 2 occasions of which at least 1 must be obtained within 365 and 90
- •days prior to study entry.
- •7. Current CD4 count at study entry of *200 cells/mm3.
- •8. Pre-cART HIV-RNA *10.000 copies/mL.
排除标准
- •1. 1. Previous virological failure, defined as either acquired resistance
- •mutations (>low level resistance) on cART or HIV-RNA >1000 copies/mL on two
- •consecutive measurements during cART.
- •2. Uncontrolled hepatitis B or C co-infection.
- •3. Prior exposure to any HDACi, BAFi or other known LRA.
- •4. Prior exposure to cytotoxic myeloablative chemotherapy for hematological
- •malignancies during cART.
- •5. Concurrent exposure to strong interacting medication on glucuronidation.
- •6. Exposure within 90 days prior to study entry to immunomodulators, cytokines,
- •systemic antifungals, dexamethasone, vitamin K antagonists, anti-epileptics,
- •antipsychotica, carbapenems, mefloquine, colestyramine, Any documented
- •opportunistic infection related to HIV in the last 90 days.
- •7. Inadequate blood counts, renal and hepatic function tests
- •a. Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females), leucocytes <2.5
- •x109/L, absolute neutrophil count <1000 cells/mm3, thrombocytes <100 x109/L,
- •international standardized ratio >1.6, activated partial thromboplastin time
- •>40 seconds.
- •b. Estimated glomerular filtration rate <50 mL/min (CKD-EPI),
- •c. ALAT or total bilirubin >2.5x upper limit of normal.
- •d. All laboratory values must be obtained within 42 days prior to the baseline
- •8. Megaloblastic anemia due to folate deficiency.
- •9. Pancreatitis in last 6 months, or chronic pancreatitis.
- •10. Active malignancy during the past year with the exception of basal
- •carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with
- •cART alone, or other indolent malignancies.
- •11. Females in the reproductive age cannot participate. Males cannot
- •participate if they refuse to abstain from sex or condom use in serodiscordant
- •sexual contact during the study, except if their sexual partner(s) use PREP.
- •12. Patients with active substance abuse or registered allergies to the
- •investigational medical products.
- •13. Last, any other condition (familial, psychological, sociological,
- •geographical) which in the investigator*s opinion poses an unacceptable risk or
- •would hamper compliance with the study protocol and follow up schedule, will
- •prohibit participation.
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