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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01606722
First received: May 24, 2012
Last updated: July 10, 2013
Last verified: July 2013

May 24, 2012
July 10, 2013
January 2010
June 2013   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01606722 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy
Relation Between Darunavir Levels and Virological Efficacy, Integrated Proviral ADN and Resistance Mutations in HIV-infected Patients on Treatment With Darunavir/Ritonavir Monotherapy

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples (plasma and PBMC)

Non-Probability Sample

HIV-infected patients who started an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010

HIV-infection
Drug: Darunavir/ritonavir
Darunavir/ritonavir (800/100 mg once daily) monotherapy
Other Name: Prezista/norvir
Darunavir-ritonavir monotherapy
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
Intervention: Drug: Darunavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01606722
LLC-DAR-2010-01, LLC-DAR-2010-01
Yes
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
Not Provided
Study Chair: Luis F Lopez-Cortes, MD, PhD. Hospital Universitario Virgen del Rocio. Sevilla. Spain
Hospitales Universitarios Virgen del Rocío
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP