Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
NCT00611039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-12-05
Summary
Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
Conditions
- HIV Infections
Interventions
- DRUG
-
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 900mg + ritonavir 100 mg once a day
- DRUG
-
Darunavir 600mg + ritonavir 100mg twice day
Darunavir 600mg + ritonavir 100mg twice day
Sponsors & Collaborators
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
collaborator OTHER -
Germans Trias i Pujol Hospital
lead OTHER
Principal Investigators
-
Bonaventura Clotet, MD,PhD · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-07-31
- Completion
- 2009-07-31
Countries
- Spain
Study Locations
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