HIV-1 positive patients
Conditions
Interventions
Trade Name: Kaletra 200 /50 mg comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration
Sponsors
Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients older than 18, HIV positive 2. Patients treated in monotherapy regimen (Lopinavir/ritonavir twice daily, 2-0-2), without any changes in the treatment regimen during the last 6 months 3. Indetectable viral load (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Opportunistic disease, neoplasy or any other active disease with specific treatment 2. Active addiction to ilegal drugs or active use of psychotropic drugs 3. Mental retardation diagnosis, or mental dementia or severe psychiatric disease (excluding major depression disorder solved > 3 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy in the control of viral replication (Viral load < 40 copies /ml);Secondary Objective: 1. Stability in plasmatic levels of Lopinavir/ritonavir during all the study visits 2. Tolerability 3. Adherence 4. Satisfaction;Primary end point(s): plasmatic viral load < 40 copies/ml at week 48;Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Stability in plasmatic levels of Lopinavir/ritonavir during all the study visits 2. Tolerability 3. Adherence 4. Satisfaction;Timepoint(s) of evaluation of this end point: All the study visits | — |
Countries
Spain
Contacts
Public ContactJuan Manuel Tiraboschi
Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
Outcome results
None listed