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

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ClinicalTrials.gov Identifier: NCT01606722

Recruitment Status : Completed

First Posted : May 28, 2012

Last Update Posted : July 11, 2013

Sponsor:

Information provided by (Responsible Party):

Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
HIV-infection	Drug: Darunavir/ritonavir

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 Design


Study Type :	Observational
Actual Enrollment :	150 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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 Start Date :	January 2010
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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	Drug: Darunavir/ritonavir Darunavir/ritonavir (800/100 mg once daily) monotherapy Other Name: Prezista/norvir

Outcome Measures

Primary Outcome Measures :

Virological efficacy [ Time Frame: 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 :

Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation [ Time Frame: 48 and 96 weeks ]
Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation

Biospecimen Retention: Samples Without DNA

Blood samples (plasma and PBMC)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606722

Locations


Spain
Hospital Universitarios Virgen del Rocio
Seville, Spain, 41013

Sponsors and Collaborators

Hospitales Universitarios Virgen del Rocío

Investigators


Study Chair:	Luis F Lopez-Cortes, MD, PhD.	Hospital Universitario Virgen del Rocio. Sevilla. Spain

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gutierrez-Valencia A, Torres-Cornejo A, BenMarzouk-Hidalgo OJ, Ruiz-Valderas R, Lluch A, Viciana P, López-Cortés 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.


Responsible Party:	Luis F. Lopez-Cortes, MD, PhD., Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:	NCT01606722 History of Changes
Other Study ID Numbers:	LLC-DAR-2010-01 LLC-DAR-2010-01 ( Other Grant/Funding Number: Consejeria de Salud. Junta de Andalucia (exp: PI-0448-2010) )
First Posted:	May 28, 2012 Key Record Dates
Last Update Posted:	July 11, 2013
Last Verified:	July 2013

Keywords provided by Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío:


Antiretroviral therapy Boosted-Darunavir monotherapy Resistance Proviral DNA-HIV

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

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