search
Back to results

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

Primary Purpose

HIV-1 Infection, Treatment Resistant Disorders, Viremia

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Protease inhibitor
Isentress® (raltegravir)
Counseling arm
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV-1, antiretroviral treatment, viral load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • HIV-1 infection
  • On combined antiretroviral regimen for at least 18 months
  • Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r ,
  • participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit.
  • 50 <or= VL < 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one.
  • Participant naïve to raltegravir (RAL)
  • failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation)
  • creatinin < 3 Upper Limit normal (ULN)
  • Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN)
  • hemoglobin > 8 g/dL
  • platelets > 50 000/mm3
  • In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method
  • Informed consent
  • Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique)

Exclusion Criteria:

  • HIV-2 infection,
  • severe medical condition in the last month (inclusion is possible for a stable condition at screening)
  • breastfeeding women, current pregnancy or planned pregnancy within 12 months.
  • participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included)
  • Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment
  • participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
  • planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)

Sites / Locations

  • Hôpital Avicenne
  • Hôpital Jean Verdier
  • Hôpital Saint André
  • Hôpital Pellegrin
  • Hôpital de la côte de Nacre
  • Hôpital Henry Mondor
  • Hôpital Européen Georges Pompidou
  • Hôpital de Bicêtre
  • Hôpital de l'Hôtel Dieu
  • Hôpital Necker
  • Hôpital Tenon
  • Hôpital Hôtel Dieu
  • Hôpital Lariboisière
  • Hôpital Saint Louis
  • Hôpital pitié Salpetrière
  • Hôpital Cochin
  • Hôpital Bichat
  • Hôpital Pontchaillou
  • Hôpital Charles Nicoll
  • Hôpital Purpan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Counseling arm

Switch arm for protease inhibitor

Addition of Isentress® (raltegravir)

Arm Description

Counseling without antiretroviral treatment modification

Switch arm for protease inhibitor : intervention is the switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.

Drug: Addition of Isentress® (raltegravir) arm • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling

Outcomes

Primary Outcome Measures

Proportion of patients in Virologic success by week 12
A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.

Secondary Outcome Measures

Proportion of participants with HIV-1 RNA < 50 copies/ml
Proportion of participants with HIV-1 RNA < 20 copies/ml
Proportion of participants with HIV-1 RNA <1copy/ml
Change in CD4 cells count from baseline
•Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count
Number of Participants With Virologic Failure and Emergence of Resistance
•resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA
Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC)
Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm
Levels of antiretroviral drugs in plasma
•plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy
Levels of antiretroviral drugs in hair
•measurement of concentrations of antiretroviral drugs treatments in hair
Levels of HIV-1 RNA in seminal plasma
quantification of HIV RNA in seminal plasma
Incidence of Study interruption
•proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure
Incidence of clinical and biological adverse events
• proportions of participants experiencing a clinical or biological adverse events (ANRS scale)
Self-reported adherence
•self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks

Full Information

First Posted
September 9, 2014
Last Updated
October 9, 2015
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Janssen-Cilag Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02247687
Brief Title
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
Official Title
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment of participants for the study
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Janssen-Cilag Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Management of participants with low-level persistent viremia
Detailed Description
ANRS 161 L-Vir is a phase III prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia. Participants will be randomized with a 1:1:1 ratio to the following three arms, Reference arm : counseling without antiretroviral treatment modification Switch arm : switch of current PI/r for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling. Addition of Isentress® (raltégravir) arm : Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, Treatment Resistant Disorders, Viremia
Keywords
HIV-1, antiretroviral treatment, viral load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling arm
Arm Type
Other
Arm Description
Counseling without antiretroviral treatment modification
Arm Title
Switch arm for protease inhibitor
Arm Type
Active Comparator
Arm Description
Switch arm for protease inhibitor : intervention is the switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
Arm Title
Addition of Isentress® (raltegravir)
Arm Type
Active Comparator
Arm Description
Drug: Addition of Isentress® (raltegravir) arm • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Intervention Type
Drug
Intervention Name(s)
Protease inhibitor
Other Intervention Name(s)
Prezista® / Norvir®
Intervention Description
Modification in the antiretroviral treatment •Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
Intervention Type
Drug
Intervention Name(s)
Isentress® (raltegravir)
Intervention Description
• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Intervention Type
Other
Intervention Name(s)
Counseling arm
Intervention Description
No change of antiretroviral treatment but only counseling
Primary Outcome Measure Information:
Title
Proportion of patients in Virologic success by week 12
Description
A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Proportion of participants with HIV-1 RNA < 50 copies/ml
Time Frame
week 4, week 8, week 12, week 24, week 36, week 48
Title
Proportion of participants with HIV-1 RNA < 20 copies/ml
Time Frame
week 4, week 8, week 12, week 24, week 36, week 48
Title
Proportion of participants with HIV-1 RNA <1copy/ml
Time Frame
week 8, week 12, week 24, week 36, week 48
Title
Change in CD4 cells count from baseline
Description
•Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count
Time Frame
week 12, week 24, week 48 and end visit
Title
Number of Participants With Virologic Failure and Emergence of Resistance
Description
•resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA
Time Frame
day 0 and visit at failure time
Title
Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC)
Description
Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm
Time Frame
day 0
Title
Levels of antiretroviral drugs in plasma
Description
•plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy
Time Frame
day 0 and end visit
Title
Levels of antiretroviral drugs in hair
Description
•measurement of concentrations of antiretroviral drugs treatments in hair
Time Frame
day 0, week 12, week 24and end visit
Title
Levels of HIV-1 RNA in seminal plasma
Description
quantification of HIV RNA in seminal plasma
Time Frame
day 0, week 12, week 48 and end visit
Title
Incidence of Study interruption
Description
•proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure
Time Frame
From day 0 to week 24
Title
Incidence of clinical and biological adverse events
Description
• proportions of participants experiencing a clinical or biological adverse events (ANRS scale)
Time Frame
from day 0 to week 48
Title
Self-reported adherence
Description
•self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks
Time Frame
day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years HIV-1 infection On combined antiretroviral regimen for at least 18 months Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r , participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit. 50 <or= VL < 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one. Participant naïve to raltegravir (RAL) failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation) creatinin < 3 Upper Limit normal (ULN) Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN) hemoglobin > 8 g/dL platelets > 50 000/mm3 In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method Informed consent Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique) Exclusion Criteria: HIV-2 infection, severe medical condition in the last month (inclusion is possible for a stable condition at screening) breastfeeding women, current pregnancy or planned pregnancy within 12 months. participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included) Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jade Ghosn, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital de la côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Henry Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
France
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital de Bicêtre
City
le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital de l'Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Hôtel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital pitié Salpetrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Charles Nicoll
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

We'll reach out to this number within 24 hrs