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

Completed

• Conditions: HIV-infection
• Interventions: Drug: Darunavir/ritonavir

• Registration Number: NCT01606722
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Darunavir-ritonavir monotherapy	Darunavir/ritonavir	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitarios Virgen del Rocio; 🇪🇸 Seville, Spain