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Experimental shot aims to revive weak immune systems in HIV patients

NCT ID NCT07443228

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tests an experimental drug called JL18008 in HIV patients whose immune systems have not fully recovered despite standard antiretroviral therapy. The study will enroll 52 adults and give them a single injection of JL18008 or a placebo. Researchers will check for side effects and measure whether the drug improves immune cell counts.

What this could mean

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

Active substance
JL18008 (an experimental drug injection)
What this could lead to
If it works, this could help HIV patients with weak immune systems better fight off infections, even when standard HIV drugs are controlling the virus.
What could go wrong
This is a very early Phase I/II trial with only 52 people. The drug may not improve immune function, and side effects are unknown. It is not a cure for 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

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 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.

Inclusion Criteria: 1. Age between 18 - 65 years old, male or female. 2. Body Mass Index (BMI) between 18 - 32 kg/m2, body weight ≥ 50 kg in male and ≥ 45 kg in female. 3. On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry. 4. Plasma HIV RNA \< 50 copies/mL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are \< 50 copies/mL). 5. During 12 months prior to study entry, CD4+ T cell counts \> 100 and ≤ 350 cells/µL measured in at least two measurements (including the screening measurement) and the interval between the two measurements should be ≥ 3 months (Note: only one time value of CD4+ T cell count \> 350 during this period will be allowed to participate if the previous and subsequent CD4+ T cell count is in the range of \> 100 and ≤ 350 cells/µL). 6. All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must practice at least one form of barrier birth control (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, other barrier contraception, etc.), during study and 3 months after the study. 7. The subject fully understands the requirements of the study and voluntarily signs the ICF. Exclusion Criteria: 1. Prior treatment with IL-7 or IL-2. 2. Allergy to JL18008 Injection components, e.g. HSA. 3. Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry. 4. Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases. 5. Any history of virus, bacteria, parasites or fungal infection and other opportunistic infections requiring systemic treatment and/or hospitalization within 30 days prior to study entry. 6. Active tuberculosis within 30 days prior to study entry. 7. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia. 8. History of splenectomy. 9. Any gastrointestinal illness associated with chronic or intermittent diarrhea. 10. Severe cardiovascular disease: myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association \> class II) or cardiac arrhythmia requiring medication within 6 months prior to study entry. 11. Hypertension with a resting systolic blood pressure \> 140 mmHg or a resting diastolic blood pressure \> 90 mmHg despite adequate antihypertensive treatment. 12. Hepatitis B Surface Antigen (HBs Ag) positive and/or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive. 13. Abnormal clinical laboratory tests results meet any of the following criteria: Hemoglobin (HGB) \< 120 g/L for men and \< 110 g/L for women; White blood cell (WBC) count \< 3.5 × 109/L; neutrophil count (NEUT) \< 1.5 × 109/L; Platelet (PLT) count \< 125 × 109/L; Creatinine (Cr) \> 1.1 × upper limit of normal value (ULN); Alanine aminotransferase (ALT) \> 1.1 × ULN; Aspartate aminotransferase (AST) \> 1.1 × ULN; Alkaline phosphatase (ALP) \> 1.1 × ULN; Total bilirubin (TBIL) \>1.1 × ULN; Phosphate level \< 2.5 mg/dL; International normalized ratio (INR) \> 1.3; Activated partial thromboplastin time (APTT) \< 1.5 × ULN. 14. Any history of HIV related encephalopathy. 15. Diagnosis of cancer within the last 5 years prior to study entry (except skin basal cell or squamous cell carrcinomas, and cutaneous Kaposi's sarcoma not requiring systemic therapy). 16. Any history of severe mental disorders or epilepsy. 17. History of drug abuse (e.g. heroin, cocaine, and crystal meth, etc.) or alcohol abuse (defined as the daily regular consumption of alcohol exceeding the following standard amount: 570 ml of beer, 750 ml of light beer, 200 ml of red wine or 60 ml of liquor, each containing about 20 g of alcohol) within 3 months prior to study entry and heavy smoker (over 20 cigarettes per day for more than 3 months) within 6 months prior to study entry. 18. Treatment with another study drug within 3 months prior to study entry. 19. History of vaccination with live attenuated vaccine in 6 weeks prior to study entry or vaccination planed during the study and within 3 months after completion of the study. 20. Pregnancy or lactation. 21. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

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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.

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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