Antiretroviral Therapy for Acute HIV Infection
研究概览
详细说明
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Kampala、乌干达
- Makerere University--Walter Reed Project (MUWRP)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
- Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
- Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
- Adult from 18 to 50 years of age.
- Able to participate for 96 weeks of study visits
- In general good health as determined by the PI or his/her designee
- Willing to have photo or fingerprint taken for identification purposes
- No history of ART for any reason, i.e., treatment naïve and no HIV-post-exposure prophylaxis (PEP) or HIV-pre-exposure prophylaxis (PrEP)) within 90 days prior to enrollment
- Willing to have blood samples collected and stored.
- Adequate renal function: estimated creatine clearance of >50 mL/min according to the Cockroft Gault formula 2 weeks prior to enrollment
- Urine clean catch: glucose < trace and protein <1+ or as per site-specification 2 weeks prior to enrollment
- Weight is > 35 kg
- Female (only women of childbearing potential) Specific Criteria:
Negative pregnancy test 48 hours prior to enrollment:
Commits to continued use of adequate birth control method for 96 weeks of the study and prior to receiving study ART. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence. If depending on hormonal contraception, check package insert for drug interactions and/or consider adding a second barrier method.
Exclusion Criteria:
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
- Untreated AIDS-related opportunistic infection
- An AIDS defining condition diagnosed within 30 days
- Positive Hepatitis B surface antigen at any time in the past
- Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
- Women who are breast-feeding
There are no inclusion/exclusion criteria based on CD4 count because CD4 count can be transiently diminished during acute HIV infection and ART initiation during early or acute HIV infection offers the potential benefit of limiting reservoir seeding and preventing immune destruction regardless of peripheral CD4 count at the time of treatment initiation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.
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Participants will receive 1 tablet per day throughout study duration (96 weeks).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Plasma viral load
大体时间:Measured at 48 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 48 weeks after enrollment
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Plasma viral load
大体时间:Measured at 96 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 96 weeks after enrollment
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Drug-related AEs and SAEs
大体时间:Measured through week 96
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Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
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Measured through week 96
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Treatment Discontinuation for AEs up to 96 weeks
大体时间:Measured through week 96
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Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
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Measured through week 96
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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CD4+ T cell count change
大体时间:Measured over 48 weeks
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CD4+ T cell count change over first 48 weeks as compared to baseline.following
the initiation of Genvoya®
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Measured over 48 weeks
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Frequency of HIV-related illnesses
大体时间:Measured through week 96
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Frequency of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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Duration of HIV-related illnesses
大体时间:Measured through week 96
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Duration of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Changes in HIV-specific immune responses over time
大体时间:Measured through week 96
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Description of changes in HIV-specific immune responses over time as characterized by intracellular cytokine staining (ICS)
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Measured through week 96
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Host humoral (IgG) responses
大体时间:Measured through week 96
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Characterization of evolution in host humoral (IgG) responses to HIV envelope over time including development of neutralizing antibody responses
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Measured through week 96
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Markers of Immune Activation
大体时间:Measured through week 96
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Description of markers of immune activation (soluble and cellular markers) by ICS.
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Measured through week 96
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HIV reservoir size
大体时间:Measured through week 96
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Evaluation of the HIV reservoir size by measurement of 1) single copy HIV RNA quantification in samples with HIV RNA <50 copies/mL and 2) total HIV DNA and integrated HIV DNA in peripheral blood
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Measured through week 96
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Neuropsychological battery performance
大体时间:Measured through week 96
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Evaluation of neuropsychological battery performance at week 48 and 96; and to later compare to RV 217 data from pre-infection and baseline early or acute HIV infection timepoints.
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Measured through week 96
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合作者和调查者
合作者
调查人员
- 学习椅:Christina Polyak, MD, MPH、Henry M. Jackson Foundation in support of MHRP
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RV 392
- WRAIR 2393 (其他标识符:WRAIR)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
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