NCT00966329

Brief Summary

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

3 active sites

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

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

August 25, 2009

Last Update Submit

January 23, 2013

Conditions

HIVHIV Infections

Keywords

SwitchingMaravirocVirological efficacyLipid profileTropism

Outcome Measures

Primary Outcomes (1)

  • Viral load

    48 weeks

Secondary Outcomes (10)

  • Time to virological failure

    48 weeks

  • Administration of lipid-lowering drugs

    48 weeks

  • Changes in the SCORE equation

    48 weeks

  • CD4 / CD8 cell counts

    48 weeks

  • Antiretroviral resistance and viral tropism

    48 weeks

  • +5 more secondary outcomes

Study Arms (2)

to switch from the NNRTI/PI to maraviroc

EXPERIMENTAL

to switch from the NNRTI/PI to maraviroc

Drug: maraviroc

to continue with the same approach

ACTIVE COMPARATOR

to continue with the same approach

Drug: control group

Interventions

maravirocDRUG

HAART regimen including 2 NRTI/NtRTIs plus maraviroc

to switch from the NNRTI/PI to maraviroc
control groupDRUG

HAART regimen including 2 NRTI/NtRTIs plus one of the following : * 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) * or ATV/unboosted (in a regimen without tenofovir) * or 1 NNRTI (nevirapine or efavirenz).

to continue with the same approach

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infected adults (=/+18 years old).
  • Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
  • Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART.
  • Patient having at least one of the following conditions:
  • Antiretroviral-related gastrointestinal disturbances, or
  • Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or
  • Any toxicity drug related.
  • Nadir CD4 cell count \> 350 cells/mm3.
  • Absence of resistance mutations in the RT or PR by (TrugeneTM)
  • Good treatment adherence.
  • Voluntary written informed consent.

You may not qualify if:

  • Virologic failure to a previous antiretroviral regimen.
  • Any antiretroviral resistance mutation in a previous resistance test.
  • Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
  • Pregnancy or fertile women willing to be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation

Badalona, Barcelona, 08916, Spain

Location

Lluita contra la Sida Foundation, HIV Unit

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Bonjoch A, Pou C, Perez-Alvarez N, Bellido R, Casadella M, Puig J, Noguera-Julian M, Clotet B, Negredo E, Paredes R. Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: a pilot, prospective, randomized clinical trial. J Antimicrob Chemother. 2013 Jun;68(6):1382-7. doi: 10.1093/jac/dks539. Epub 2013 Jan 25.

    PMID: 23354282DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

MaravirocControl Groups

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)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eugènia Negredo, MD,PhD

    Lluita contra la Sida Foundation, HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dra. Eugenia Negredo

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

ES(3)