NCT00808002

Brief Summary

The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection. This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.

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_3 hiv-infections

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 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

December 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

December 12, 2008

Last Update Submit

January 30, 2020

Conditions

HIV Infections

Keywords

MaravirocCCR5 antagonistsPrimary HIV InfectionHIV-1 reservoireradicationtreatment naive

Outcome Measures

Primary Outcomes (1)

  • Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.

    BL, W2, W4, W12, W24, W48

Secondary Outcomes (10)

  • Decay of residual HIV-1 replication under maraviroc intensification assessed by an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL.

    BL, W2, W4, W8, W12, W24, W36, W48

  • Blips during the study (viral load >50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls).

    From Baseline to W48

  • HIV-1 RNA below 50 copies/mL at 48 weeks.

    W48

  • Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48.

    BL, W4, W12, W24, W48, W60, W72

  • Relationship between maraviroc and/or raltegravir plasma concentrations and change in the slope of decay of integrated viral DNA in PBMCs

    W12, W24, W48

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

From Baseline to Week48: Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID From W48 to W72: Raltegravir BID + Tenofovir/Emtricitabine QD

Drug: RaltegravirDrug: MaravirocDrug: Tenofovir/Emtricitabine

2

ACTIVE COMPARATOR

Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine

Drug: RaltegravirDrug: Tenofovir/Emtricitabine

Interventions

RaltegravirDRUG

Raltegravir 400 mg every 12 hours

12
MaravirocDRUG

Maraviroc 300 mg every 12 hours

1
Tenofovir/EmtricitabineDRUG

Tenofovir/Emtricitabine 300/200 mg every 24 hours

12

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected adults (\>=18 years old).
  • No previous antiretroviral therapy for more than 2 weeks.
  • HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.
  • CCR5-tropism confirmed at screening.
  • Voluntary written informed consent.

You may not qualify if:

  • Pregnancy or fertile women willing to be pregnant.
  • Active substance abuse or major psychiatric disease.
  • Presence of NRTI mutations in the screening genotype.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir PotassiumMaravirocTenofovirEmtricitabine

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)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesOrganophosphonatesOrganophosphorus CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Bonaventura Clotet, MD,PhD

    LLuita contra la SIDA Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

  • Josep Mª Llibre, MD,PhD

    LLuita contra la SIDA Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Bonaventura Clotet

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 15, 2008

Study Start

February 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

ES(2)