NCT00611039

Brief Summary

Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4 hiv-infections

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

First Submitted

Initial submission to the registry

January 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

January 28, 2008

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

Darunavir/ritonavirvirtual inhibitory quotientdose reduction

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HIV-1 viral load < 50 copies /mL

    Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48

Secondary Outcomes (9)

  • DRV plasma trough concentration

    Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  • DRV Virtual inhibitory quotient (vIQ)

    Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  • CD4 and CD8 lymphocytes count

    Screening, Basal, week 12, week 24, week 36 and week 48

  • Physical examination including weight and height

    Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  • Karnofsky index

    Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Darunavir 900mg + ritonavir 100 mg once a day

Drug: Darunavir 900mg + ritonavir 100 mg once a day

2

ACTIVE COMPARATOR

Darunavir 600mg + ritonavir 100mg twice day

Drug: Darunavir 600mg + ritonavir 100mg twice day

Interventions

Darunavir 900mg + ritonavir 100 mg once a dayDRUG

Darunavir 900mg + ritonavir 100 mg once a day

1
Darunavir 600mg + ritonavir 100mg twice dayDRUG

Darunavir 600mg + ritonavir 100mg twice day

2

Eligibility Criteria

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

You may qualify if:

  • Age \>= 18 years.
  • HIV-infected patients.
  • Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
  • HIV viral load \< 50 copies/mL for at least 12 weeks.
  • Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
  • Darunavir vIQ \>= 2.
  • Subject able to follow the treatment period.
  • In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
  • Signature of the informed consent.

You may not qualify if:

  • AIDS-defining illness in the last 4 weeks.
  • Suspicion of unsuitable antiretroviral treatment compliance.
  • In women, pregnancy or breastfeeding.
  • Record or suspicion of incapability to cooperate as appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.

    PMID: 20386077DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

DarunavirRitonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bonaventura Clotet, MD,PhD

    Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

ES(1)