HIV patients with virological treatment failure due to multi-drug-resistant virus including 3TC resistance
Conditions
Interventions
Trade Name: Epivir
Product Name: Epivir
Product Code: 3TC
Pharmaceutical Form: Tablet
Sponsors
Prof. Dr. med. Milos Opravil, Universitätsspital Zürich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Prior documented intolerance of 3TC. • Patients participating in other clinical trials. • Patients receiving immunomodulators or undergoing structured treatment interruptions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether in patients with virologic failure due to multi-drug resistant virus including 3TC resistance, maintenance of CD4 lymphocytes within a level that implies no severe immune deficiency may be achievable with 3TC monotherapy. This would be of particular benefit for patients who suffer from adverse events of their current ART. With 3TC monotherapy, future treatment options with other drugs and drug classes will be preserved and adverse events associated with a new salvage therapy avoided. The study endpoints will be: - Time to CD4 decrease by 30% or below 200 cells/µl - Number of patients who will need to re-start HAART again within 12 months - Adverse events associated with 3TC monotherapy ;Secondary Objective: At study end, we will evaluate whether the study endpoints correlate with any of the following: - highly impaired RC (30%) at baseline - CD4 lymphocyte levels at baseline and as nadir - HIV RNA set point prior to ART (if available) - HIV RNA at baseline and during the study ;Primary end point(s): CD4 from baseline (average week –2 and 0) to week 24 and 48. Secondary endpoints: Time course of RC, genotypic and phenotypic resistance, HIV RNA, p24 antigen, RT activity, adverse events, and clinical course. Secondary endpoints: Time course of RC, genotypic and phenotypic resistance, HIV RNA, p24 antigen, RT activity, adverse events, and clinical course. | — |
Countries
Germany
Outcome results
None listed