ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 .

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 38 participants screened between July 2012 and January 2015, 30 (78.9%) participants were finally included.

Reporting Groups
  Description
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate

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.


Participant Flow:   Overall Study
    Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate
STARTED   30 
COMPLETED   28 
NOT COMPLETED   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate

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.


Baseline Measures
   Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   30 
<=18 years      0   0.0% 
Between 18 and 65 years      27  90.0% 
>=65 years      3  10.0% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 
Participants Analyzed   30 
   48.8 
 (46.0 to 52.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   30 
Female      20  66.7% 
Male      10  33.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
France   
Participants Analyzed   30 
France   30 


  Outcome Measures

1.  Primary:   Percentage of Participants in Therapeutic Success   [ Time Frame: at Week 48 ]

2.  Secondary:   Median Change in CD4 Lymphocytes Count at Week 12   [ Time Frame: between Week 0 and Week 12 ]

3.  Secondary:   Number of Clinical and Biological Events   [ Time Frame: from Week 0 to Week 48 ]

4.  Secondary:   Median Change of CD4 Lymphocytes at Week 48   [ Time Frame: between Week 0 and Week 48 ]

5.  Secondary:   Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL   [ Time Frame: between Week 0 and Week 48 ]

6.  Secondary:   Number of Participants With Clinical Progression   [ Time Frame: from Week 0 to Week 48 ]

7.  Secondary:   Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence   [ Time Frame: from Week 4 to Week 48 ]

8.  Secondary:   Number of Virological Failure Participants With Resistance Mutations   [ Time Frame: from Week 0 to Week 48 ]

9.  Secondary:   Number of Participants With Treatment Switch or Discontinuation   [ Time Frame: from Week 0 to Week 48 ]

10.  Secondary:   Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48   [ Time Frame: at Week 48 ]

11.  Secondary:   Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire   [ Time Frame: from Week 0 to Week 48 ]

12.  Secondary:   Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: sophie.matheron@aphp.fr



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