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

HIV-infection Clinical Trial

— MonDar  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606722
• Other study ID #: LLC-DAR-2010-01
• Secondary ID: LLC-DAR-2010-01
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: July 10, 2013
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-infection

Intervention

Drug:
• Darunavir/ritonavir
Darunavir/ritonavir (800/100 mg once daily) monotherapy

Locations

Country	Name	City	State
Spain	Hospital Universitarios Virgen del Rocio	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 and 96 weeks	No
Secondary	Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation	Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation	48 and 96 weeks	No