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Small HIV study tests safety of Virus-Waking drugs

NCT ID NCT05230368

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage trial tested whether a combination of two HIV-1 activators is safe for people with HIV subtype B who are on standard antiretroviral therapy and have undetectable virus levels. Nine men participated, and the study focused on tracking side effects. The goal was to gather safety data, not to treat or cure HIV.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Dec 2022

Finished

Dec 2025

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

18 to 69 years

Sex

Male participants only

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: * Man aged 18-69 years; * Man with documented infection with sub-type B HIV-1; * On cART since more than 36 months before pre- screening and at a stable regimen for at least 2 months before pre-screening and until inclusion; * HIV plasma viral load persistently \< the threshold (of the local test used) and undetectable during the 12 months prior to pre-screening and until inclusion; * CD4+ T-cells count nadir ≥ 200 cells per mm3 documented in the medical file; Transient CD4+ T-cells count \< 200 cells per mm3 is allowed for a short period if the value is associated with a single isolated acute infection * CD4+ T-cells count ≥ 500 cells per mm3 for at least 12 months before pre-screening and until inclusion; * EBV viral load \< 1000 cp.mL-1, CMV viral load \< 10000 cp mL-1; * Able and willing to comply with study visits and procedures as per protocol; * Able to understand, sign and date the written voluntary informed consent form at the pre screening visit prior to any protocol-specific procedures. * Free, informed and written consent signed by the person and the investigator (at the latest on the day of pre-screening and before any investigation carried out as part of the trial) (law of 7 May 2004. article 6) Exclusion Criteria: * Man who want to father a child or refuse contraception (condoms) while receiving treatment and for 3 months following completion of treatment; Man with a female partner of childbearing potential who refuses to use a highly effective contraceptive method during the same period (Experimental treatment period and for 3 months following completion of experimental treatment). * Clinically significant cardiac disease including QTc-prolongation (QTc value \> 450msec); * On PI based regimen or regimen containing NNRTI (except Doravirine which is allowed), Ritonavir or Cobicistat; * Treated with CYP 450 inducer or inhibitor, in particular dexamethasone, carbamazepine, phenytoin, rifabutin, rifapentine and phenobarbital; * Treated with anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation; * Treated with warfarin or coumarin derivative; * History of an AIDS-defining clinical illness (based on CDC classification); * Active coinfection with viral hepatitis B; * Active coinfection with viral hepatitis C; * Received any vaccination within 4 weeks prior to the first administration of the study products and plan to receive throughout the study (with the exception of influenza and COVID-19 vaccines which can be injected 4 weeks after the last administration of the study products as well as the Monkeypox vaccination that will be allowed during trial if participant becomes a contact at risk for monkeypox infection (according to national recommendations)); * Treated with sexual hormone during the administration period of the study treatments (until CXD32); * Active malignancy that may require chemotherapy or radiation therapy; * Any significant acute medical illness in the 8 weeks prior to pre-screening and until inclusion; * Haematological or biochemical laboratory parameters at pre-screening and screening : Hemoglobin (\<LLN), absolute neutrophil count (\<LLN), platelets (\<LLN), INR (\>1.2), Partial Thromboplastin Time (\>ULN); grade ≥ 2 for the following parameters: Total serum Creatinine, urea, uric acid, glycemia, total serum bilirubin, Alkaline Phosphatase (ALP) AST-ALT, gammaglutamyl transferase (GGT), lipasemia, LDH, Ionogram: Na, K, Ca, Mg, CRP, albumin, proteins, CPK; * Liver insufficiency (Child Pugh score \>5); * Kidney insufficiency (Estimation of glomerular filtration\<60mL/mn/1,73m2 ; evaluation with CKDepi formula, according to the 2012 French Haute autorité de santé recommandations); * Participant under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision * Participant potentially inable to follow the protocol requirements (e.g. comprehension of the study requirements, ability to understand and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits). * Participating to another interventional study or still in an exclusion period from another clinical trial ; * Planning to participate in a study within 3 months after the end of the present trial.

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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

  • Antoine CHERET

    Le Kremlin-Bicêtre, 94275, France

  • CHU Saint-Pierre

    Brussels, 1000, Belgium

  • LAMBOTTE Olivier

    Le Kremlin-Bicêtre, 94276, France

  • Odile LAUNAY

    Paris, 75000, France