STUDY TO EVALUATE THE EFFICACY, SAFETY AND ECONOMIC IMPACT OF REDUCING DOSES OF DARUNAVIR IN PATIENTS INFECTED WITH HIV TREATED WITH DARUNAVIR / RITONAVIR ONCE A DAY

• Conditions: HIV-infected patients on stable treatment with darunavir / ritonavir 800/100 mg qd plus two transcriptase inhibitors, nucleoside analogs for at least 4 weeks.; MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-006272-39-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-10
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

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

Inclusion Criteria

- Treatment stable with darunavir / ritonavir 800/100 mg qd plus two nucleoside analogs transcriptase inhibitors for at least 4 weeks.
- HIV viral load in plasma <50 copies / mL for at least 12 weeks.
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 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- AIDS-defining disease in the previous 4 weeks.
-Virologic failure history previous antiretroviral treatment regimens that included protease inhibitor drugs.
- Presence of darunavir resistance mutations documented in previous genotypes.

Study & Design

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