PER-002-23尚未招募2 期
Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with Both Chronic Hepatitis B and HIV.
Instituto Nacional de Alergias y Enfermedades Infecciosas NIAID0 个研究点目标入组 0 人开始时间: 2024年2月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- 性别
- All
入选标准
- •HIV-1, documented by:
- •Any licensed rapid HIV test or HIV enzyme or chemiluminescence
- •immunoassay (E/CIA) test kit at any time prior to study entry
- •Confirmed by one of the following:
- •o A second antibody test from different manufacturers or based
- •on different principles and epitopes (combination antigenantibody-based rapid tests may be used)
- •o HIV-1 antigen
- •o HIV-1 RNA viral load, or
- •o A licensed Western blot
- •NOTE: The term licensed” refers to a US FDA-approved kit WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or an HIV-1 RNA viral load.
- •Effective antiviral therapy for both HIV (ART) and HBV for =5 years immediately prior to study entry, that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV). ART is defined as including a minimum of two anti-HIV antivirals.
- •NOTE A: Switches are allowed as long as the regimen contains TDF, TAF, or ETV and as long as the participant has maintained HIV and HBV suppression for at least 12 months immediately prior to study entry.
- •NOTE B: Interruptions are permitted; however, in the 12 months prior to study entry, an interruption in therapy of up to 2 weeks on one occasion only is permitted, as long as the interruption occurred at least 24 weeks prior to study entry.
- •CD4+ cell count =350 cells/mm3 obtained within 60 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any Network-approved non-US laboratory that is DAIDS Immunology Quality Assurance (IQA) certified.
- •Positive or negative HBeAg result obtained within 60 days prior to study entry from any US laboratory that has CLIA certification or its equivalent, or at any Network-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs (non-US sites).
- •Negative hepatitis D virus antibody (anti-HDV) result obtained as measured by Network-approved central laboratory within 60 days prior to study entry.
- •Quantitative HBsAg >1000 IU/mL measured within 60 days prior to study entry
- •as measured by Network-approved central laboratory.
排除标准
- •Known allergy/sensitivity or any hypersensitivity to components of study drug or
- •its formulation.
- •Active substance use or dependence that, in the opinion of the site investigator,
- •would interfere with adherence to study requirements.
- •Unwillingness to consent to genetic testing.
- •Receipt of PEG-IFN within 4 weeks prior to study entry.
- •Enrollment in or discontinuation of an investigational product or nonapproved drug within 4 weeks or 5 half-lives of last dosing, whichever is
- •longer, prior to study entry.
- •Presence of any active or acute AIDS-defining opportunistic infections within 60
- •days prior to study entry. A list of AIDS-defining opportunistic infections is located
- •on the PSWP.
- •History of or active uveitis or posterior synechiae.
- •Acute or serious illness requiring systemic treatment and/or hospitalization within
- •60 days prior to study entry.
- •Screening electrocardiogram (ECG) with clinically significant abnormalities
- •or with QTcF interval (QT corrected using Fridericia’s formula) >450 msec
- •for males or >470 msec for females
- •Receipt of potent CYP3A inhibitors and inducers, including atazanavir, ritonavir,
- •cobicistat, efavirenz, etravirine (ETR), or nevirapine within 2 weeks prior to study
- •Breastfeeding or pregnancy.
- •History of HCC or cholangiocarcinoma.
- •Acute illness within 7 days prior to study entry.
- •Receipt of any vaccine within 14 days prior to study entry
- •Current receipt and/or anticipated need during the study of prohibited
- •medications listed in Table 5.4.2-1.
研究者
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