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HIV pill combo simplifies treatment for patients over 45

NCT ID NCT02212379

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a two-drug combination of raltegravir and etravirine in 170 adults with HIV who were at least 45 years old and already had the virus well-controlled. Participants switched from a standard three-drug regimen to this simpler two-pill combo. After 96 weeks, over 98% still had undetectable virus levels, suggesting this approach could be a safe and effective option for older adults living with HIV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
raltegravir and etravirine (oral tablets)
What this could lead to
If successful, this could offer a simpler, two-drug option for older adults with HIV, reducing pill burden and side effects while keeping the virus suppressed.
What could go wrong
This was a small, single-arm phase II study with no comparison group. Results may not apply to all patients, and long-term risks or resistance are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

170 people

The number who actually took part.

Start date

Jan 2015

Finished

Apr 2018

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • CHU Hôtel Dieu

    Nantes, 44093, France

  • Hospital Clinic

    Barcelona, 08036, Spain

  • Hospital de Bellvitge

    Barcelona, 08000, Spain

  • Hospital de la santa Creu i San Pau

    Barcelona, 08025, Spain

  • Hôpital Avicenne

    Bobigny, 93000, France

  • Hôpital Bichat Claude Bernard

    Paris, 75018, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital Bretonneau

    Tours, 37044, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Croix Rousse

    Lyon, 69317, France

  • Hôpital Européen Georges Pompidou

    Paris, 75908, France

  • Hôpital Gui de Chauliac

    Montpellier, 34000, France

  • Hôpital Jean Verdier

    Bondy, 93140, France

  • Hôpital Necker

    Paris, 75015, France

  • Hôpital Pitié-Salpétrière

    Paris, 75013, France

  • Hôpital Saint André

    Bordeaux, 33076, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • Hôpital Sainte marguerite

    Marseille, 13009, France

  • Hôpital de l'Archet

    Nice, 06202, France

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