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
  Purpose

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


Condition Intervention
HIV-infection
Drug: Darunavir/ritonavir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Blood samples (plasma and PBMC)


Enrollment: 150
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 24, 2012
Last Updated: July 10, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospitales Universitarios Virgen del Rocío:
Antiretroviral therapy
Boosted-Darunavir monotherapy
Resistance
Proviral DNA-HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014