An observational study in HIV-infection, sponsored by Hospitales Universitarios Virgen del Rocío. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-11.
Sponsored by Hospitales Universitarios Virgen del Rocío · Observational
To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 150 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Hospitales Universitarios Virgen del Rocío is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-infected patients who started an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010
Exclusion Criteria:
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
Drug: Darunavir/ritonavir
Darunavir/ritonavir (800/100 mg once daily) monotherapy
Also known as: Prezista/norvir
Virological efficacy
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.
Time frame: 48 and 96 weeks
Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation
Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation
Time frame: 48 and 96 weeks
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Hospitales Universitarios Virgen del Rocío