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
- Conditions
- HIV patients with virological treatment failure due to multi-drug-resistant virus including 3TC resistance
- Registration Number
- EUCTR2004-002633-39-DE
- Lead Sponsor
- Prof. Dr. med. Milos Opravil, Universitätsspital Zürich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method