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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02247687
Other study ID # ANRS 161 L-Vir
Secondary ID 2014-001663-13
Status Terminated
Phase Phase 3
First received September 9, 2014
Last updated October 9, 2015
Start date December 2014
Est. completion date September 2015

Study information

Verified date October 2015
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Management of participants with low-level persistent viremia


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


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 (ßHCG) 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 ...)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Protease inhibitor
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.
Isentress® (raltegravir)
• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Other:
Counseling arm
No change of antiretroviral treatment but only counseling

Locations

Country Name City State
France Hôpital Avicenne Bobigny
France Hôpital Jean Verdier Bondy
France Hôpital Pellegrin Bordeaux
France Hôpital Saint André Bordeaux
France Hôpital de la côte de Nacre Caen
France Hôpital Henry Mondor Creteil
France Hôpital Européen Georges Pompidou France
France Hôpital de Bicêtre le Kremlin Bicêtre
France Hôpital de l'Hôtel Dieu Nantes
France Hôpital Bichat Paris
France Hôpital Cochin Paris
France Hôpital Hôtel Dieu Paris
France Hôpital Lariboisière Paris
France Hôpital Necker Paris
France Hôpital pitié Salpetrière Paris
France Hôpital Saint Louis Paris
France Hôpital Tenon Paris
France Hôpital Pontchaillou Rennes
France Hôpital Charles Nicoll Rouen
France Hôpital Purpan Toulouse

Sponsors (2)

Lead Sponsor Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. week 12 Yes
Secondary Proportion of participants with HIV-1 RNA < 50 copies/ml week 4, week 8, week 12, week 24, week 36, week 48 No
Secondary Proportion of participants with HIV-1 RNA < 20 copies/ml week 4, week 8, week 12, week 24, week 36, week 48 No
Secondary Proportion of participants with HIV-1 RNA <1copy/ml week 8, week 12, week 24, week 36, week 48 No
Secondary Change in CD4 cells count from baseline •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count week 12, week 24, week 48 and end visit No
Secondary 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 day 0 and visit at failure time No
Secondary 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 day 0 No
Secondary Levels of antiretroviral drugs in plasma •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy day 0 and end visit No
Secondary Levels of antiretroviral drugs in hair •measurement of concentrations of antiretroviral drugs treatments in hair day 0, week 12, week 24and end visit No
Secondary Levels of HIV-1 RNA in seminal plasma quantification of HIV RNA in seminal plasma day 0, week 12, week 48 and end visit No
Secondary Incidence of Study interruption •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure From day 0 to week 24 No
Secondary Incidence of clinical and biological adverse events • proportions of participants experiencing a clinical or biological adverse events (ANRS scale) from day 0 to week 48 No
Secondary Self-reported adherence •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit No
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