EUCTR2011-005981-39-ESActive, not recruitingPhase 1
Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once daily - KMO
nidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge0 sitesStarted: January 30, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (<40 copies/ml) during the last 6 months
- •4. Patients that accept the participation in the sudy and sign the ICF
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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)
Investigators
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