EUCTR2007-006448-23-GB进行中（未招募）1 期
A randomised controlled trial of a strategy of switching to boosted protease inhibitor monotherapy versus continuing combination antiretroviral therapy for the long-term management of HIV-1 infected patients who have achieved sustained virological suppression on highly-active antiretroviral therapy - Protease Inhibitor monotherapy Vs Ongoing Triple-therapy (PIVOT)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 587
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
- •INCLUSION CRITERIA
- •1. Documented HIV infection on ELISA and confirmatory test.
- •2. Male or female patients, aged 18 years or more.
- •3. Receiving combination ART for at least 24 weeks with a regimen comprising 2 NRTIs and either an NNRTI or a PI (boosted or un-boosted).
- •4. No change in ART drugs in the 12 weeks prior to screening.
- •5. Plasma VL <50 copies/ml at screening and for at least 24 weeks prior to screening (must have at least 1 documented result <50 copies/ml at more than 24 weeks prior to screening, and at least 1 documented result <50 copies/ml taken within 24 weeks prior to screening). A patient who has had one VL blip” to <200 copies/ml in the 24 weeks prior to screening may be included, provided that the 2 VL tests that immediately preceded the blip and all the VL tests(of which there must be at least 1 prior to screening) that immediately followed the blip all gave results <50 copies/ml.
- •6. CD4+ count >100 cells/mm3 at screening.
- •(This criterion is included because immune reconstitution is a priority in patients with very low CD4+ counts, and there is currently insufficient data to assess whether PI monotherapy will lead to equivalent rates of CD4+ recovery as standard-of-care treatment.)
- •7. Willing to continue unchanged or to modify, antiretroviral therapy, in accordance with the randomised assignment.
- •8. Likely to be resident in the UK for the full duration of the trial and willing to comply with trial visit schedule throughout the follow-up period.
- •9.Willing to provide written informed consent.
- •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 375
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •EXCLUSION CRITERIA
- •1. Known major protease resistance mutation(s) documented on prior resistance testing if performed (prior resistance testing is not mandatory for trial participation).
- •2. Previous change in ART drug regimen for reasons of unsatisfactory virological response (patients who have changed regimen for prevention or managemnt of toxicity or to improve regimen convenience are permitted to enter the trial).
- •3. Previous allergic reaction to a PI.
- •4. Patient currently using or likely to require use of concomitant medication with known interaction with PI s including rifampicin, amiodarone, flecainide, bupropion, clozapine, ergotamine, mexilitine, midazolam, pethidine, pimozide, quinidine, sertindole, sildenafil, voriconazole, zolpidem, St John’s Wort.
- •5. Patient requiring treatment with radiotherapy, cytotoxic chemotherapy, or is anticipated to need these during the trial period.
- •6. Treatment for acute opportunistic infection within 3 months prior to trial screening.
- •7. Pregnant or trying to become pregnant at the time of trial entry.
- •8. History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments.
- •9. History of HIV encephalopathy with current deficit >1 in any domain of the Neuropsychiatric AIDS Rating Scale.
- •10. Past or current history of cardiovascular disease, or 10 year absolute coronary heart disease risk of >30%, or risk of >20% if the patient has diabetes or a family history of premature ischaemic heart disease or stroke(based on the Framingham equation and assessed using the Joint British Societies cardiovascular risk prediction charts).
- •11. History of insulin-dependent diabetes mellitus.
- •12. Patient currently receiving interferon therapy for Hepatitis C virus infection or planning to start treatment for Hepatitis C at the time of study entry.
- •13. Co-infection with hepatitis B, defined as Hepatitis BsAg positive at screening or at any time since HIV diagnosis, unless the patient has had a documented Hepatitis B DNA measurement of less than 1000 copies/ml taken whilst off Hepatitis B active drug.
- •(This criterion is included to avoid the risk of a flare of Hepatitis B with NRTI withdrawal.)
- •14. Any other active clinically significant condition, or findings during screening medical history or examination or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial.
- •15. Fasting plasma glucose > 7.0mmol/L at trial screening.
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