Clinical trial NCT01606722: Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infection
Keywords: Antiretroviral therapy
Boosted-Darunavir monotherapy
Resistance
Proviral DNA-HIV
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients who started an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010

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.

Eligibility 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

Primary outcomes:
measure: Virological efficacy
timeFrame: 48 and 96 weeks
Secondary outcomes:
measure: Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation
timeFrame: 48 and 96 weeks
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitarios Virgen del Rocio
Study officials:
affiliation: Hospital Universitario Virgen del Rocio. Sevilla. Spain
name: Luis F Lopez-Cortes, MD, PhD.
role: STUDY_CHAIR
References:
citation: Gutierrez-Valencia A, Torres-Cornejo A, BenMarzouk-Hidalgo OJ, Ruiz-Valderas R, Lluch A, Viciana P, Lopez-Cortes LF. Darunavir minimum plasma concentration and ritonavir-boosted darunavir monotherapy outcome in HIV-infected patients. Antivir Ther. 2014;19(5):443-7. doi: 10.3851/IMP2722. Epub 2014 Jan 16.