HIV-infection
Conditions
Keywords
Antiretroviral therapy, Boosted-Darunavir monotherapy, Resistance, Proviral DNA-HIV
Brief summary
To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
Detailed description
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.
Interventions
Darunavir/ritonavir (800/100 mg once daily) monotherapy
Sponsors
Hospitales Universitarios Virgen del Rocío
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virological efficacy | 48 and 96 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation | 48 and 96 weeks | Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation |
Countries
Spain
Outcome results
None listed