Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy (MonDar)
To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Relation Between Darunavir Levels and Virological Efficacy, Integrated Proviral ADN and Resistance Mutations in HIV-infected Patients on Treatment With Darunavir/Ritonavir Monotherapy|
- Virological efficacy [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]To correlate the plasma and intracellular (cell-associated)) DRV levels with the virological efficacy analyzed by the time to loss of virological response (TLOVR) algorithm, considering VF as either: 1) two consecutive viral load >200 copies/mL, 2) a unique HIV-RNA >200 copies/mL if followed by lost to follow-up, or 3) the reintroduction of nucleos(t)ides because any reason.
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation
Biospecimen Retention: Samples Without DNA
Blood samples (plasma and PBMC)
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
HIV-infected patients with undetectable viral load for at least for 6 months on stable therapy and no darunavir related mutations in the HIV-protease gene
Darunavir/ritonavir (800/100 mg once daily) monotherapy
Other Name: Prezista/norvir
To be enrolled, subjects had a plasma HIV-RNA <50 copies/mL for at least 6 months based, virologic failure while on a PI-containing regimen was allowed if the genotypic resistance tests showed no major resistance mutation associated to reduced susceptibility to DRV/rtv according to the International AIDS Society. Patients with transitory episodes of detectable plasma HIV-RNA viral load ("blip") preceded and followed by a plasma viral load <50 copies/mL without changes in antiretroviral treatment could also been included. The only exclusion criteria were pregnancy, hepatitis B coinfection and the concomitant use of drugs with potential major interactions with DRV/rtv pharmacokinetics.
|Hospital Universitarios Virgen del Rocio|
|Seville, Spain, 41013|
|Study Chair:||Luis F Lopez-Cortes, MD, PhD.||Hospital Universitario Virgen del Rocio. Sevilla. Spain|