Prospective study of switch to 3TC monotherapy with evaluation of replication capacity in patients with virologic failure and 3TC resistance (a multicenter prospective clinical study within the SHCS) SHCS-Projekt Nr. 408 - 3TC Mono Study

Prof. Dr. med. Milos Opravil, Universitätsspital Zürich0 个研究点目标入组 30 人开始时间: 2004年12月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Documented HIV-1 infection with clade B virus.
•Patients undergoing resistance testing because of virologic failure, defined as two consecutive HIV RNA values >400 copies/ml with the second one >1000 copies/ml.
•Currently on (for at least 3 months) stable HAART (3 or more antiretroviral drugs).
•CD4 >300/µl and no active opportunistic infection.
•HIV RNA 1000 – 100'000 copies/ml.
•Presence of the 184V or 184I RT mutation, or 3TC phenotypic resistance.
•Additional resistance, defined as either genotypic mutations to at least one additional major NRTI (K65R; 69 insertion; T69D,N; L74I,V; V75A,T; Q151L,M; T215F,Y) and at least one major PI (D30N; G48V; I50N; V82A,F,S,T; I84V,A; L90M) mutation; or as a phenotypic resistance to at least one additional NRTI and one protease inhibitor.
•Written informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Prior documented intolerance of 3TC.
•Patients participating in other clinical trials.
•Patients receiving immunomodulators or undergoing structured treatment interruptions.

发起方

Prof. Dr. med. Milos Opravil, Universitätsspital Zürich