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New injectable HIV combo trial pulled before it began

NCT ID NCT06657885

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This was a planned phase 2 study to test a combination of two long-acting drugs, cabotegravir and lenacapavir, for people with HIV who have tried many treatments. The goal was to see if switching to these injections every two months could keep the virus under control. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

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

Active substance
cabotegravir and lenacapavir (injectable and oral forms)
What this could lead to
If successful, this could offer a new long-acting injectable option for HIV patients who have difficulty with daily pills or have drug resistance.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no data was collected. The combination is still experimental and may not prove effective or safe in larger studies.

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.

Expected to start

Jan 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 90 years

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.

Age ≥ 18 years * HIV-1 infection * Stable oral antiretroviral treatment for at least 6 months * Multi-treated patients who have received multiple lines of antiretroviral treatment * Undetectable patients with CV \< 50 copies/mL in the last 6 months (a single blip between 50 and 200 copies/mL in the last 6 months is allowed) and eligible to switch to the lenacapavir/cabotegravir strategy on the basis of a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to * the presence of resistance mutations, including to NNRTIs * or oral drug intolerance * or drug-drug interactions * Detectable, virologically uncontrolled HIV viral load ≥ 200 c/mL in the last 12 months who is eligible to switch to the lenacapavir/cabotegravir strategy based on a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to * the presence of resistance mutations, including to NNRTIs * or oral drug intolerance * or drug-drug interactions * ASAT and ALAT \< 3N * Creatinine GFR \> 60 mL/min (CKD-EPI) * Haemoglobin \> 10 g/dL * Platelets \> 100 000/mm3 * Commitment to use preventive and protective means of sexual intercourse for the duration of the trial. * For women at risk of pregnancy, commitment to use an effective method of contraception for the duration of the study. * Affiliated or beneficiary of a social security scheme (article L1121-11 of the French Public Health Code), * Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study (article L1122-1-1 of the French Public Health Code). Non-inclusion criteria * HIV-2 infection or HIV-1/HIV2 co-infection * HIV-1 subtype A6/A1 * BMI ≥ 30kg/m². * Chronic active viral hepatitis B with positive Hbs antigen * Active chronic viral hepatitis C requiring specific treatment over the next 48 weeks. * Treatment with interferon, interleukin or any other immunotherapy or chemotherapy in progress. * Active opportunistic infection, or acute treatment for opportunistic infection * Any condition (alcohol, drugs, neurological or neuropsychiatric disorders, etc.) likely to compromise tolerance of treatment and/or patient compliance with treatment and adherence to the protocol, as judged by the investigator. * Women who are breastfeeding, pregnant or refusing contraception * Taking medication contraindicated with the trial treatment * Major incapacity, legal protection, guardianship or curatorship * Planning to move house within the next 18 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU de nantes- Hotel Dieu

    Nantes, France

  • Centre hospitalier François Mitterrand

    Dijon, France

  • Centre hospitalier de Tourcoing

    Tourcoing, France

  • Chu- Nice Archet

    Nice, France

  • Hopital Bichat Claude Bernard

    Paris, 75018, France

  • Hopital Necker

    Paris, 75015, France

  • Hopital Pitié Salpêtrière

    Paris, 75013, France

  • Hopital Saint André

    Bordeaux, France

  • Hopital Saint Antoine

    Paris, 75012, France

  • Hopital raymond Poincaré

    Garches, France

  • Hopiytal Pellegrin

    Bordeaux, France

  • Hôpital Franco-Britannique

    Levallois-Perret, France

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