Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once daily

Phase 1

• Conditions: HIV-1 positive patients; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005981-39-ES
• Lead Sponsor: nidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified