se of genotypic HIV-1 tropism testing in proviral DNA to guide CCR5 antagonist treatment in subjects with undetectable HIV-1 viremia

Fundació Lluita contra la SIDA0 个研究点目标入组 135 人开始时间: 2011年11月3日最近更新: 2014年6月2日

试验速览

暂无简介。

•Adult (18 years or more), HIV-1 infected patients.
•Antiretroviral treatment for at leasdt 6 months containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)
•Viral load under 50 copies/mL in the last 6 months
•Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.
•A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.
•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 135
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 135

•Pregnancy or breast-feeding.
•Patient previously treated with maraviroc.
•Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.
•Viral failure in the moment of inclusion.
•Bad adherence history or anticipated (investigator criteria).

发起方

Fundació Lluita contra la SIDA