NCT00454337

Brief Summary

Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide (or : with an enfuvirtide-based combination therapy)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3 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

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

March 29, 2007

Last Update Submit

November 6, 2012

Conditions

HIV Infections

Keywords

HIV-1 infectionenfuvirtideraltegravirtreatment experienced

Outcome Measures

Primary Outcomes (1)

  • comparison of the proportions of virologic failure, defined as two consecutive pVL above 400 cp per ml, through 24 weeks in enfuvirtide-maintained arm versus raltegravir arm

    W24

Secondary Outcomes (10)

  • comparison of time to onset of virologic failure

    W24 and W48

  • proportions of pts with pVL under 50 and 400 cp per ml respectively at week 24 and week 48 ;

    W24 & W48

  • plasma viral mutations in the event of virologic failure, compared to HIV-DNA archived mutations at baseline;

    virologic failure

  • change in CD4 levels

    between W0 and W48

  • incidence of HIV-related events

    between W0 and W48

  • +5 more secondary outcomes

Study Arms (2)

Intensification arm

EXPERIMENTAL

emtricitabine/TDF + efavirenz or lopinavir/ritonavir + enfuvirtide

Drug: FTC/TDF + EFV or LPV/R +T20

Standard arm

ACTIVE COMPARATOR

emtricitabine/TDF + efavirenz or lopinavir/ritonavir

Drug: FTC/TDF + EFV or LPV/R

Interventions

FTC/TDF + EFV or LPV/R +T20DRUG

emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day) + enfuvirtide 90mg twice a day

Intensification arm
FTC/TDF + EFV or LPV/RDRUG

emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day)

Standard arm

Eligibility Criteria

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

You may qualify if:

  • Chronic HIV-1 infection
  • Treatment with a well-tolerated combination of antiretroviral drugs unchanged for at least 3 months, including enfuvirtide
  • Absence of any uncontrolled opportunistic disease
  • No restrictions on CD4 lymphocyte levels
  • For women of childbearing age, use of mechanical contraception during any sexual intercourse and negative pregnancy test (plasma ß HCG) at W -4

You may not qualify if:

  • HIV-2 infection
  • Poor compliance with antiretroviral therapy current at W -4
  • Current treatment with an investigational drug (except cohort ATU)
  • Patient previously treated with an integrase inhibitor in the context of a clinical study
  • Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception
  • Multiple drug therapy ongoing or necessary in the foreseeable future for Kaposi's disease or lymphoma
  • Treatment with interferon ongoing or necessary in the foreseeable future for chronic hepatitis B or C
  • Acute hepatitis whatever the case, or decompensated cirrhosis
  • Current treatment with interferon, interleukin or anti-HIV vaccine
  • Any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol
  • Significant biological abnormalities (hemoglobin below 8g per dl, polynuclear neutrophils below 750 per mm3, platelets below 50,000 per mm3, serum creatinine above 3 times the level deemed normal by the laboratory (N), ASAT or ALAT above 5N, serum lipase above 2N) and total bilirubin above 2N (except if the patient is receiving atazanavir or indinavir)
  • Concomitant treatments including one or more compounds interacting with UGT1A1
  • anti-infective agents: rifampicin/rifampin
  • psychotropic/anti-epileptic drugs: phenytoin, phenobarbital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des maladies infectieuses et tropicales Hopital Saint Louis

Paris, 75010, France

Location

Related Publications (9)

  • Goldwirt L, Braun J, de Castro N, Charreau I, Barrail-Tran A, Delaugerre C, Raffi F, Lascoux-Combe C, Aboulker JP, Taburet AM, Molina JM. Switch from enfuvirtide to raltegravir lowers plasma concentrations of darunavir and tipranavir: a pharmacokinetic substudy of the EASIER-ANRS 138 trial. Antimicrob Agents Chemother. 2011 Jul;55(7):3613-5. doi: 10.1128/AAC.01827-10. Epub 2011 May 16.

    PMID: 21576452RESULT

  • Barau C, Delaugerre C, Braun J, de Castro N, Furlan V, Charreau I, Gerard L, Lascoux-Combe C, Molina JM, Taburet AM. High concentration of raltegravir in semen of HIV-infected men: results from a substudy of the EASIER-ANRS 138 trial. Antimicrob Agents Chemother. 2010 Feb;54(2):937-9. doi: 10.1128/AAC.01261-09. Epub 2009 Dec 7.

    PMID: 19995925RESULT

  • Delaugerre C, Charreau I, Braun J, Nere ML, de Castro N, Yeni P, Ghosn J, Aboulker JP, Molina JM, Simon F; ANRS 138 study group. Time course of total HIV-1 DNA and 2-long-terminal repeat circles in patients with controlled plasma viremia switching to a raltegravir-containing regimen. AIDS. 2010 Sep 24;24(15):2391-5. doi: 10.1097/QAD.0b013e32833d214c.

    PMID: 20683319RESULT

  • Boulet T, Pavie J, Charreau I, Braun J, Reynes J, Morlat P, Piroth L, Spire B, Molina JM, Aboulker JP; Easier-Anrs 138 Study Group. Impact on health-related quality of life of a switch from enfuvirtide to raltegravir among multidrug-resistant HIV-1-infected patients: a randomized open-label trial (EASIER-ANRS 138). HIV Clin Trials. 2010 Sep-Oct;11(5):283-93. doi: 10.1310/hct1105-283.

    PMID: 21126958RESULT

  • Gallien S, Delaugerre C, Charreau I, Braun J, Boulet T, Barrail-Tran A, de Castro N, Molina JM, Kuritzkes DR. Emerging integrase inhibitor resistance mutations in raltegravir-treated HIV-1-infected patients with low-level viremia. AIDS. 2011 Mar 13;25(5):665-9. doi: 10.1097/QAD.0b013e3283445834.

    PMID: 21326075RESULT

  • Gallien S, Braun J, Delaugerre C, Charreau I, Reynes J, Jeanblanc F, Verdon R, de Truchis P, May T, Madelaine-Chambrin I, Aboulker JP, Molina JM; EASIER ANRS 138 Study Group. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. J Antimicrob Chemother. 2011 Sep;66(9):2099-106. doi: 10.1093/jac/dkr269. Epub 2011 Jun 28.

    PMID: 21712241RESULT

  • Delaugerre C, Braun J, Charreau I, Delarue S, Nere ML, de Castro N, May T, Marchou B, Simon F, Molina JM, Aboulker JP; ANRS 138-EASIER study group. Comparison of resistance mutation patterns in historical plasma HIV RNA genotypes with those in current proviral HIV DNA genotypes among extensively treated patients with suppressed replication. HIV Med. 2012 Oct;13(9):517-25. doi: 10.1111/j.1468-1293.2012.01002.x. Epub 2012 Mar 14.

    PMID: 22416781RESULT

  • de Castro N, Braun J, Charreau I, Lafeuillade A, Viard JP, Allavena C, Aboulker JP, Molina JM; EASIER ANRS 138 study group. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. AIDS Res Ther. 2016 Apr 2;13:17. doi: 10.1186/s12981-016-0101-3. eCollection 2016.

    PMID: 27042193DERIVED

  • De Castro N, Braun J, Charreau I, Pialoux G, Cotte L, Katlama C, Raffi F, Weiss L, Meynard JL, Yazdanpanah Y, Delaugerre C, Madelaine-Chambrin I, Aboulker JP, Molina JM; EASIER ANRS 138 study group. Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009 Oct 15;49(8):1259-67. doi: 10.1086/605674.

    PMID: 19757993DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nathalie De Castro, MD

    AP-HP Hopital Saint Louis Paris

    PRINCIPAL INVESTIGATOR

  • Jean M Molina, MD

    AP-HP Hopital saint Louis Paris

    PRINCIPAL INVESTIGATOR

  • Jean P Aboulker, MD

    INSERM SC10 Villejuif France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

FR(1)