EUCTR2017-000437-32-GB进行中（未招募）1 期
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose- Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination with Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults - Dose Ranging Trial of MK-8591 Given in Combination Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has HIV-1 infection as determined by a positive enzyme-linked immunosorbent assay and a screening plasma HIV-1 RNA (completed by the central laboratory) =1,000 copies/mL within 60 days of the treatment phase of the study
- •2. Has a screening CD4+ T-cell count =200 cells/mm3 (completed by the central laboratory) within 60 days prior to the treatment phase of this study
- •3. Is naïve to ART
- •Note: Naïve is defined as having received no (0 days) ART therapy for the treatment of active HIV-1 infection including prevention of mother-to-child transmission
- •4. Has the following laboratory values (completed by the central laboratory) within 60 days prior to the treatment phase of this study:
- •a) International normalized ratio =1.2
- •b) Urine protein is within normal limits (no more than trace protein by urine dipstick)
- •c) Hemoglobin =9.0 g/dL if female or =10.0 g/dL if male
- •d) Absolute neutrophil count =1000/mm3
- •e) Platelet count =100,000/mm3
- •f) Total serum bilirubin =the upper limit of normal (ULN)
- •g) Alkaline phosphatase <1.5 × ULN
- •h) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 × ULN
- •5. Has a calculated creatinine clearance (Clcr) =50 mL/min within 60 days prior to the treatment phase of this study , based Cockcroft-Gault equations
- •6. In the opinion of the investigator, the participant should be considered clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study)
- •7. Is a male or female at least 18 years of age on the day informed consent is signed
- •8. A female participant is eligible to participate if she is not pregnant (see Appendix 5 of the protocol), not breastfeeding, and at least one of the following conditions applies:
- •a.) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5
- •b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 6 weeks (corresponding to time needed to eliminate any study treatments (MK-8591, DOR, or 3TC) or MK-1439A after the last dose of study treatment
- •9. All participants, male and female, agree to use barrier methods of
- •contraception when engaged in any sexual activity during treatment and
- •for 6 weeks following treatment
- •10. The participant (or legally acceptable representative, if applicable) provides written informed consent for the trial. The participant (or legally acceptable representative, if applicable) may also provide consent for Future Biomedical Research. However, the participant may enroll in the main trial without consenting to Future Biomedical Research
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate
- •2. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a history of drug or alcohol abuse or dependence that may interfere with trial participation. The nature and potential clinical context of the participant's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the investigator
- •3. Has significant hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator
- •4. Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •5. Is female and is expecting to donate eggs at any time during the study (donation of sperm should follow local guidelines for HIV-positive individuals)
- •6. Is breastfeeding or expecting to conceive
- •7. A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •8. Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, the following: adefovir, TDF, TAF, entecavir, FTC, or 3TC
- •9. Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
- •10. Requires or is anticipated to require any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John’s Wort, Modafinil, Bosentan, Nafcillin, Pentostatin
- •11. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial
- •12. Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor, or any study drug, as demonstrated by any the following resistance substitutions (according to the 2017 IAS-USA drug resistance mutations list [Wensing, A. M., et al 2017]):
- •a) NRTI resistance substitutions: RT M41L, K65E/N/R, D67N, T69Insert, K70E/R, L74V, V75I, F77L, Y115F, F116Y, Q151M, M184I/V, L210W, T215F/Y, K219E/Q. This list includes all resistance substitutions that may also impact study drugs MK-8591, 3TC, or TDF
- •b) NNRTI resistance substitutions: RT L100I, K101E/P, K103N/S, V106A/I/M, V108I, E138A/G/K/Q/R, V179L, Y181C/I/V, Y188C/H/L, G190A/S, H221Y, P225H, F227C/L/V, M230I/L, L234I, P236L, or Y318F. This list includes all resistance substitutions that may also impact study drug DOR
- •c) Protease inhibitor resistance substitutions: Protease D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, I54L/M, Q58E, T74P, L76V, V82A/F/L/S/T, N83D, I84V, N88S, orL90M
- •d) Integrase inhibitor resistance substitutions: Integrase T66I, E92Q, F121Y, 143C/H/R, S147G, Q148H/K/R, or N155H
- •13. Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or HBV c
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