ISRCTN44453201已完成4 期
A Phase IV, randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in virologically suppressed HIV-1 infected adults harbouring drug resistance mutations
niversity of Sussex0 个研究点目标入组 100 人开始时间: 2019年6月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32689975/ protocol (added 22/07/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 23/07/2021:
- •1. 18 years and above
- •2. On a bPI-based ART regimen with documented HIV-1 RNA <50 copies/mL for at least 6 months on current regimen and at screening (A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF), lamivudine (3TC) to emtricitabine (FTC), or splitting co-formulated tablets to their individual component or vice versa will not be considered true regimen changes)
- •3. Must have a historical genotype
- •4. Eligible drug resistance mutations in historical genotype include at least one of the following:
- •4.1. M184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S)
- •4.2. M184V/I alone (maximum of 20 participants with isolated M184V/I mutation with or without NNRTI mutations)
- •4.3. Up to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I
- •4.4. Any of the above with or without NNRTI mutations
- •5. If previous INSTI exposure, participants should not have experienced virological failure on the INSTI regimen. Site must provide viral load history during the time participant was on INSTI for Chief Investigator review and confirmation of eligibility. Participants who experienced one of the following whilst on INSTI regimen will be excluded:
- •5.1. Viral load =50 copies/ml on two consecutive occasions
- •5.2. A single blip” viral load =500 copies/ml
- •5.3. 3 or more blips” (viral load 50 -500 copies/ml)
- •6. No known INSTI mutations
- •7. Estimated GFR = 50 mL/min (Cockcroft-Gault formula)
- •8. Have the following laboratory values at screening within 30 days prior to baseline (note: a single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results):
- •8.1. Alkaline phosphatase = 3.0 x upper limit of normal (ULN)
- •8.2. AST and ALT = 5.0 x ULN
- •8.3. Haemoglobin =9.0 g/dL (female) or =10.0 g/dL (male)
- •9. Provides written, informed consent to participate
- •10. Is willing to comply with the protocol requirements
- •11. If female and of child bearing potential and are willing to continue practising one of the following:
- •11.1. Must be using effective birth control methods, that is has an expected failure rate of <1% per year and willing to continue practicing these birth control measures during the trial and for at least 30 days after the end of the trial. Effective methods include IUD, combined pill, contraceptive injection, implant, IUS, contraceptive vaginal ring, contraceptive patches etc.
- •11.2. Must be truly abstinent from penile-vaginal intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 30 days after the end of the trial (When this is in line with the preferred and usual lifestyle of the participant.) Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not
- •acceptable methods of contraception. Note: women who are postmenopausal for least 2 years, women with a total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential.
- •12. If male, and sexually-active with female partners of child bearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial.
- •Previous participant inclusion criteria as of 15/01/2020:
- •1. 18 years and above
- •2. On a bPI-based ART regimen with at least one documented HIV-1 RNA < 50 copies/m
排除标准
- •Current participant exclusion criteria as of 23/07/2021:
- •1. Exclusion under drug resistance mutations include:
- •1.1. Presence of any of the following mutations: K65R/N/E
- •1.2. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y
- •1.3. Presence of INSTI mutations: H51Y, T66AIK, E92QGV, G118R, F121Y, E138KAT, G140ASC, Y143CRHKSGA, P145S, Q146P, S147G, Q148HKRN, S153YF, N155HSTD, S230R, R263K
- •1.4. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R)
- •2. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
- •3. An opportunistic illness within the 30 days prior to screening
- •4. Active tuberculosis infection
- •5. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine based therapies)
- •6. Current alcohol or substance use judged by the Investigator to potentially interfere with participants’ adherence to study procedure.
- •7. A history of malignancy of less than 2 years or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study.
- •8. Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection)
- •9. Any pre-existing physical or mental health condition which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants. Subjects considered to pose a significant risk of suicide should be excluded.
- •10. Any known allergies to the excipients of B/F/TAF FDC
- •11. Females who are pregnant (as confirmed by positive urine pregnancy test)
- •12. Females who are breastfeeding
- •13. Women of child bearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection)
- •14. Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct acting antivirals in study
- •15. Any concomitant medications that cannot be administered with TAF (i.e strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins)
- •Previous participant exclusion criteria as of 15/01/2020:
- •1. Exclusion under drug resistance mutations include:
- •1.1. Presence of any of the following mutations: K65R/N/E
- •1.2. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y
- •1.3. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R)
- •2. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
- •3. An opportunistic illness within the 30 days prior to screening
- •4. Active tuberculosis infection
- •5. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobu
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