Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospitales Universitarios Virgen del Rocío
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Older than 18 years, starting an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010

• Plasma RNA-VIH < 50 copies/ml on stable antiretroviral treatment for ≥ 6 months

• Absence of resistance mutations in the protease gene, based on treatment history and/or genotypic resistance testing. that would decrease darunavir susceptibility

Exclusion Criteria:

• Pregnancy

• Chronic B hepatitis

• Genotypic resistance tests with evidence of resistance mutations in the protease gene that would decrease darunavir susceptibility

• Concomitant use of drugs with potentially adverse interactions with darunavir-ritonavir pharmacokinetics, such as rifampin