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Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)

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ClinicalTrials.gov Identifier: NCT01605890
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Gilead Sciences
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-2 Infection
Intervention Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .
Enrollment 30
Recruitment Details The study enrolled ART-naïve adults infected with HIV-2 only with history of CDC group B or C event, or a CD4 count <500 cells/μL, or a CD4 decrease >50 cells/μL/year over the past 3 years, or a confirmed plasma HIV-2 RNA (pVL) ≥100 copies (cp) /mL from 18 hospital centers in France.The last participant completed in December 2015.
Pre-assignment Details Of the 38 participants screened between July 2012 and January 2015, 30 (78.9%) participants were finally included.
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  90.0%
>=65 years
3
  10.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants
48.8
(46.0 to 52.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
20
  66.7%
Male
10
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 30 participants
30
1.Primary Outcome
Title Percentage of Participants in Therapeutic Success
Hide Description

The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:

  • Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,
  • CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,
  • Raltegravir permanent discontinuation,
  • Death from any cause,
  • New B or C events confirmed by an endpoint review committee
Time Frame at Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(22.7 to 59.4)
2.Secondary Outcome
Title Median Change in CD4 Lymphocytes Count at Week 12
Hide Description [Not Specified]
Time Frame between Week 0 and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: cells/µL
73
(2 to 143)
3.Secondary Outcome
Title Number of Clinical and Biological Events
Hide Description [Not Specified]
Time Frame from Week 0 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: clinical and biological events
61
4.Secondary Outcome
Title Median Change of CD4 Lymphocytes at Week 48
Hide Description [Not Specified]
Time Frame between Week 0 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 28
Median (Inter-Quartile Range)
Unit of Measure: cells/µL
87
(38 to 213)
5.Secondary Outcome
Title Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
Hide Description [Not Specified]
Time Frame between Week 0 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of participants
96.4
6.Secondary Outcome
Title Number of Participants With Clinical Progression
Hide Description

Clinical progression is defined as the switch:

  • from category A to B, C or death.
  • from category B to C or death.
Time Frame from Week 0 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
Hide Description [Not Specified]
Time Frame from Week 4 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with available questionnaire of adherence
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
76
8.Secondary Outcome
Title Number of Virological Failure Participants With Resistance Mutations
Hide Description Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported.
Time Frame from Week 0 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
9.Secondary Outcome
Title Number of Participants With Treatment Switch or Discontinuation
Hide Description Overall (regardless of the molecule)
Time Frame from Week 0 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
  13.3%
10.Secondary Outcome
Title Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
Hide Description [Not Specified]
Time Frame at Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available measurements
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
11.Secondary Outcome
Title Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire
Hide Description

The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:

Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated.

Time Frame from Week 0 to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available PROQOL questionnaire
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 22
Median (Inter-Quartile Range)
Unit of Measure: Score on a scale
45
(20 to 75)
12.Secondary Outcome
Title Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available measurement
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description:

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.8%
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Hide Arm/Group Description

emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.

All-Cause Mortality
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Affected / at Risk (%) # Events
Total   4/30 (13.33%)    
Infections and infestations   
Helicobacter pylori gastritis, Escherichia coli cystitis  1 [1]  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Truvada overdose without any adverse event  1 [2]  1/30 (3.33%)  1
Nervous system disorders   
Lacunar ischemic stroke  1 [3]  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Suspected recurrence of bronchopulmonary cancer  1 [3]  1/30 (3.33%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
Also functionnal colopathy referring to the SOC=Gastrointestinal disorders
[2]
Other medically important condition
[3]
Hospitalisation or prolongation of existing Hospitalisation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
Affected / at Risk (%) # Events
Total   14/30 (46.67%)    
Blood and lymphatic system disorders   
Neutropenia  1  2/30 (6.67%)  2
Leuco-neutropenia  1  2/30 (6.67%)  2
Gastrointestinal disorders   
Nausea  1  5/30 (16.67%)  5
Abdominal pain  1  2/30 (6.67%)  2
General disorders   
Asthenia  1  4/30 (13.33%)  4
Infections and infestations   
Nasopharyngitis  1  2/30 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Backache  1  2/30 (6.67%)  2
Nervous system disorders   
Headache  1  2/30 (6.67%)  2
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Pr Sophie Matheron
Organization: Hopital Bichat-Claude Bernard, AP-HP, Paris, France
Phone: +33140257883
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01605890     History of Changes
Other Study ID Numbers: 2011-005038-20
ANRS 159 VIH-2
First Submitted: May 22, 2012
First Posted: May 25, 2012
Results First Submitted: March 10, 2017
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018