Status:
COMPLETED
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the dru...
Eligibility Criteria
Inclusion
- Age \>= 18 years.
- HIV-infected patients.
- Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
- HIV viral load \< 50 copies/mL for at least 12 weeks.
- Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
- Darunavir vIQ \>= 2.
- Subject able to follow the treatment period.
- In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- Signature of the informed consent.
Exclusion
- AIDS-defining illness in the last 4 weeks.
- Suspicion of unsuitable antiretroviral treatment compliance.
- In women, pregnancy or breastfeeding.
- Record or suspicion of incapability to cooperate as appropriate.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00611039
Start Date
February 1 2008
End Date
July 1 2009
Last Update
December 5 2019
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916