NCT01378910

Brief Summary

CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1 tropism in proviral DNA could be helpful to inform in which of these subjects CCR5 antagonists could be efficacious.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for phase_4 hiv

Timeline
Completed

Started Jun 2011

Typical duration for phase_4 hiv

Geographic Reach
1 country

24 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

Study Start

First participant enrolled

June 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 14, 2019

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

June 17, 2011

Last Update Submit

November 11, 2019

Conditions

HIV

Keywords

HIVTROPISMPBMCGENOTYPE454 SEQUENCING

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with viral load under 50 copies/mL

    Week 48

Secondary Outcomes (36)

  • Percentage of patients without confirmed virological failure.

    Up to week 48

  • Time to loss of virological response (TLOVR) < 200 copies/mL

    Up to week 48

  • Time to loss of virological response (TLOVR) < 50 copies/mL

    Up to week 48

  • Proportion of patients treated with maraviroc with viral load under 50 copies/mL

    Week 12

  • Proportion of patients treated with maraviroc with viral load under 50 copies/mL

    Week 24

  • +31 more secondary outcomes

Study Arms (1)

Change of 3rd drug to maraviroc

EXPERIMENTAL

Change of PI, NNRTI or integrase inhibitor to CCR5 antagonist (maraviroc)

Drug: Unique

Interventions

UniqueDRUG

Change of PI, NNRTI or integrase inhibitor to CCR5 antagonist (maraviroc)

Change of 3rd drug to maraviroc

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infected patients.
  • Age 18 or more.
  • Antiretroviral treatment containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)
  • Patients receiving stable antiretroviral treatment for at least 6 months.
  • Viral load under 50 copies/mL in the last 6 months
  • Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.
  • A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.
  • An antiretroviral regimen containing a CCR5-antagonist is suitable for the patient (physician criteria).
  • Voluntary written informed consent.

You may not qualify if:

  • Pregnancy or breast-feeding.
  • Patient previously treated with maraviroc.
  • Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.
  • Bad adherence history or anticipated (investigator criteria).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Hospital Xeral de Vigo

Santiago de Compostela, A Coruña, 15781, Spain

Location

Hospital de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07011, Spain

Location

H. U. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

H. de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital U. Marqués de Valdecilla

Santander, Cantabria, 39011, Spain

Location

Hospital General de Castellón

Castellon, Castelló, 12004, Spain

Location

Hospital Sta. Lucía/ H. Sta. Mª del Rosell

Cartagena, Murcia, 30203, Spain

Location

Hospital de Cruces

Bilbao, Vizcaya, 48903, Spain

Location

Hospital Gral. U. de Alicante

Alicante, 03010, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de Mataró

Barcelona, 08304, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital U. San Cecilio

Granada, 28012, Spain

Location

Hospital U. Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Carlos III

Madrid, 28029, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Reina Sofía de Murcia

Murcia, 30003, Spain

Location

Hospital Sant Pau i Santa Tecla

Tarragona, 43007, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

Hospital Gral. U. de Valencia

Valencia, 46014, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital U. Dr. Peset

Valencia, 46017, Spain

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

November 14, 2019

Record last verified: 2014-07

Locations

ES(24)