A randomised, open label study to evaluate the efficacy and safety of maraviroc(MVC) as a switch for N(t)RTI or PI/r in HIV1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of cART. - MARCH study

niversity of New South Wales0 个研究点目标入组 380 人开始时间: 2011年10月13日最近更新: 2019年6月30日

试验速览

暂无简介。

•1. Documented HIV 1 infection by a licensed diagnostic test at any time prior to study entry
•2. Age >18 years
•3. HIV 1 RNA <200 copies/mL plasma for at least 24 weeks
•4. Stable (>24 weeks) ART including two N(t)RTIs and a PI/r
•5. No evidence of any primary HIV genotypic mutations in HIV reverse transcriptase or protease for all patients with available resistance testing results conducted prior to cART and/or during viral rebound/failure
•6. Provision of 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 544
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•1. CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a nonreportable tropism result based on assessment using proviral DNA
•2. Anticipated need to modify current cART regimen for toxicity management in the next 6 months
•3. The following laboratory criteria,
•a. absolute neutrophil count (ANC) <750 cells/µL
•b. haemoglobin <8.0 g/dL
•c. platelet count <50,000 cells/µL
•d. serum AST, ALT >5 x upper limit of normal (ULN)
•4. Active hepatitis B coinfection
•5. Pregnant women or nursing mothers
•6. Current use of any prohibited medications as described in product specific information.
•7. Hypersensitivity to soy or peanuts
•8. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation
•9. Use of immunomodulators (e.g. systemic corticosteroids, recombinant interleukin 2 interferon) within 30 days prior to screening
•10. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the study
•11. Patients unlikely to be able to remain in follow up for the protocol defined
•12. Prisoners or subjects who are compulsorily detained (involuntary incarcerated).

发起方