NL-OMON50519已完成3 期
A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants (study 201584, FLAIR) - study 201584, FLAIR
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
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
- •* HIV-1 infected, ART-naive men or women aged 18 years or older.
- •* HIV-1 infection as documented by Screening plasma HIV-1 RNA *1000 c/mL.
- •* Antiretroviral-naïve (*10 days of prior therapy with any antiretroviral agent
- •following a diagnosis of HIV-1 infection). Any previous exposure to an HIV
- •integrase inhibitor or NNRTI will be exclusionary.
排除标准
- •* Women who are pregnant, breastfeeding, or plan to become pregnant or
- •breastfeed during the study.
- •* All active CDC stage 3 diseases at screen are exclusionary, except cutaneous
- •Kaposi*s sarcoma (not requiring systemic therapy) or historic or current CD4+
- •cell count <200 cells/mm3.
- •* Known moderate to severe hepatic impairment.
- •* High risk of seizures, see protocol page 70 for details.
- •* Significant suicide risk, see protocol page 70-71 for details.
- •* Evidence of Hepatitis B virus, see protocol page 71 for details.
- •* Asymptomatic individuals with chronic hepatitis C virus infection will not be
- •excluded, see protocol page 71 for details.
- •* Untreated syphilis infection, see protocol page 72 for details.
- •* Clinically significant cardiovascular disease, see protocol page 72 for
- •* Concomitant medications, see protocol page 72 for details.
- •* Any evidence of primary resistance to NNRTIs, see protocol page 73 for
- •* HLA-B*5701 positive and are unable to use an NRTI backbone that does not
- •contain abacavir, see protocol page 73 for details.
- •* Any verified Grade 4 laboratory abnormality.
- •* Estimated creatinine clearance <50 mL/min/1.73m2.
- •* Currently participating in or anticipating to be selected for any other
- •interventional study.
研究者
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