Efficacy of dual antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir in early rescue therapy in patients with HIV-1 infection: pilot, multicenter, randomized, controlled and open phase II clinical trial. BIMARTHE study - Bimarthe

Vall d'Hebron Institut de Recerca (VHIR)0 个研究点目标入组 90 人开始时间: 2013年1月9日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•- Adult patients with HIV-1 infection
•- Virologic failure, definded as two consecutive HIV RNA levels > 400 cop/ml within 2-6 weeks, when being under stable ART for at least 3 months
•- Genotipic resistance to lamivudine/emtricitabine (M184V/I) irrespective of other NRTIs or NNRTIs associated mutations. Patients with current or previous virologic failure to an IP/r based regimen may be included if the number of IPs associated mutations is ? 2 and there are no IPs primary resistances or DRV associated mutations
•- CCR5 viral tropism determined by V3 sequencing. The period between the determination of viral tropism and inclusion in the study will be 6 weeks maximum
•- Informed consent
•- Women without reproductive potential and not breastfeeding.
•- Women with reproductive potential if they are not breastfeeding and who meet the following criteria:
•* Negative pregnancy test at baseline
•* Accept commit to avoid pregnancy until 30 days after the last dose of study drug, by using double barrier method of contraception or abstinence.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- AIDS defining event within 48 weeks before starting study
•- Current HIV RNA load > 100.000 cop/ml
•- Current CD4+ cell count < 100 cel/mm³
•- HBV coinfection (HBsAg positive)
•- Descompensated liver cirrhosis (Child-Pugh B/C)
•- Chronic renal failure (Clearance of creatinine MDRD < 30 ml/min/1,73m2)
•- Patients unable to understant the study prtocol or candidates who, in researcher opinion, are not appropiate to be enroled in the study
•- Pregnant, lactating or with reproductive potential women, who not commit to avoid pregnancy until 30 days after the last dose of study drug.

发起方

Vall d'Hebron Institut de Recerca (VHIR)