AzTrials
AzTrials

HIV-1 InfectionPhase 2NCT02212379

Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL

A Phase 2 study testing raltegravir and etravirine in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
raltegravir and etravirine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
19 sitesin 2 countries
Study dates
Jan 2015to Apr 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented HIV-1 infection
  • Age ≥ 45 years
  • Naïve to integrase inhibitor and etravirine
  • At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs
  • HIV-RNA plasma VL ≤ 50 copies/mL during the last 24 months prior to screening visit (Week-6/Week-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL
  • HIV-RNA plasma VL ≤ 50 copies/mL at screening visit (Week-6/Week-4)
Show all 17Show fewer
  • A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the medical history of the patient) and shows a virus sensitive to ETR OR no genotype is available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the medical history of the patient), there are no virological failure on NNRTI in the medical history
  • CD4+ lymphocytes > 200 cells/mm3
  • Creatinine < 2.5 x ULN
  • CPK (Creatine Phospho Kinase) < 6 ULN (Upper Limit of Normal)
  • AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) < 5 ULN
  • Hemoglobin > 10 g/dL
  • Platelets > 100 000/mm3
  • Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential
  • For French participants only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme), article L1121-11 of the Public health code
  • Patients with a coverage from a social health
  • Signed informed consent

Who cannot join

  • Previous exposure to raltegravir or etravirine
  • Presence of any documented integrase inhibitor mutation on DNA genotype at Week-6/Week-4 and/or on RNA in the medical history of the patient
  • Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac
  • HIV-2 infection
  • Active viral hepatitis C requiring a specific treatment during the 24 months of the trial
  • Patient with a history of non-compliance or irregular follow-up
Show all 14Show fewer
  • Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic treatment within the last 3 months prior the screening visit (Week-6 /Week-4)
  • Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam (Halcion®)
  • Concomitant treatment using interferon, interleukins or any other immunotherapy or chemotherapy
  • Concomitant prophylactic or curative treatment for an opportunistic infection
  • All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
  • Subjects under judicial protection due to temporarily and slightly diminished mental or physical faculties, or under legal guardianship
  • Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
  • Pregnant women or breastfeeding women

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

France16 sites

  • Hôpital Avicenne

    Bobigny, 93000

  • Hôpital Jean Verdier

    Bondy, 93140

  • Hôpital Saint André

    Bordeaux, 33076

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hôpital Croix Rousse

    Lyon, 69317

  • Hôpital Sainte marguerite

    Marseille, 13009

  • Hôpital Gui de Chauliac

    Montpellier, 34000

  • CHU Hôtel Dieu

    Nantes, 44093

  • Hôpital de l'Archet

    Nice, 06202

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Pitié-Salpétrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Necker

    Paris, 75015

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Hôpital Bretonneau

    Tours, 37044

Other trials in France

Spain3 sites

  • Hospital de Bellvitge

    Barcelona, 08000

  • Hospital de la santa Creu i San Pau

    Barcelona, 08025

  • Hospital Clinic

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study

This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy >90%, assuming a success rate >95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.

Conditions
HIV-1 Infection
Being tested
raltegravir and etravirine
Keywords
Raltegravir, Etravirine, aged, 45 and over, Viral load, Efficacy, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • raltegravir and etravirineDrug

    Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

    Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.

Study groups in NCT02212379
Study groupRoleWhat they receive
raltegravir and etravirineExperimentalNot described
Receives: Drug: raltegravir and etravirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96

    Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.

    The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96

    Measured: at week48 and at week 96

Secondary outcomes (23)

  1. Percentage of Patients With Therapeutic Success at Week 48 and Week 96

    Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure

    Measured: weeks 48 and 96

  2. Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96

    Measured: weeks 48 and 96

  3. Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)

    Measured: weeks 48 and 96

  4. Median Time of Virological Failure

    Time between the date of the study treatment initiation and the date of virological failure

    Measured: week 96

  5. Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL

    Measured: weeks 48 and 96

  6. Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure

    Measured: week 96

  7. Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL

    Measured: week 96

  8. Evolution of Total Cell-associated HIV-DNA

    Measured: from day 0 to week 48 and week 96

  9. Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio

    Measured: from day 0 to week 48 and week 96

  10. Number of Participants Experiencing Adverse Events and Effects

    Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.

    Measured: From day 0 to week 48 and week 96

  11. Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)

    Measured: from day 0 to week 96

  12. Evolution of the Calibrated 5-year Framingham Risk Score

    The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.

    Median percent change expressed as median (interquartile range (IQR))

    Measured: from day 0 to week 48 and at week 96

  13. Percent Change of Renal Function

    Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula

    Measured: from day 0 to week 96

  14. Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)

    Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96

    Measured: from day 0 to week 96

  15. Sub-study: Bone Mineral Density

    • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)
    • Lumbar spine BMD, mg/cm2
    • Total hip BMD, mg/cm2

    Measured: from day 0, to week 48 and week 96

  16. Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48

    • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48

    Measured: week 48

  17. Inflammatory Parameters

    • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots

    Measured: from day 0 to week 96

  18. Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96

    Measured: day 0 and weeks 48 and 96

  19. Percentage of Participants Compliant With Treatment Program.

    The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).

    Measured: at week 0, week 48, and week 96

  20. Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots

    We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)

    Measured: from day 0, to week 48

  21. Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples

    Measured: from day 0, to week 48

  22. Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96

    Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.

    Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.

    Ovarian reserve measure is AMH

    Measured: from day 0, to week 96

  23. Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status

    BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean

    Measured: from day 0, to week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2017
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02212379
Sponsor's protocol ID
ANRS 163 ETRAL
Other IDs
2014-000828-24, 2014
Status last verified
Mar 2021
First submitted
30 Jul 2014
Last updated
3 Apr 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing raltegravir and etravirine in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96 (time frame: at week48 and at week 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in