NCT01606722

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.4 years

First QC Date

May 24, 2012

Last Update Submit

July 10, 2013

Conditions

HIV-infection

Keywords

Antiretroviral therapyBoosted-Darunavir monotherapyResistanceProviral DNA-HIV

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation

    48 and 96 weeks

Study Arms (1)

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

Interventions

Darunavir/ritonavirDRUG

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

Also known as: Prezista/norvir
Darunavir-ritonavir monotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitarios Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24434370DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (plasma and PBMC)

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

DarunavirRitonavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Study Officials

  • Luis F Lopez-Cortes, MD, PhD.

    Hospital Universitario Virgen del Rocio. Sevilla. Spain

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD.

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

ES(1)