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

NCT ID: NCT01606722

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

HIV-infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Darunavir/ritonavir

Intervention Type: DRUG

Darunavir/ritonavir (800/100 mg once daily) monotherapy

Interventions

Darunavir/ritonavir

Darunavir/ritonavir (800/100 mg once daily) monotherapy

Intervention Type: DRUG

Other Intervention Names

Prezista/norvir

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role: lead

Responsible Party

Luis F. Lopez-Cortes

MD, PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis F Lopez-Cortes, MD, PhD.

Role: STUDY_CHAIR

Hospital Universitario Virgen del Rocio. Sevilla. Spain

Locations

Hospital Universitarios Virgen del Rocio

Seville, Seville, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 24434370 (View on PubMed)

Other Identifiers

LLC-DAR-2010-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LLC-DAR-2010-01

Identifier Type: -

Identifier Source: org_study_id