Can a One-Two punch wake up and destroy hidden HIV?
NCT ID NCT07577986
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a combination therapy to target hidden HIV reservoirs. Twenty HIV-positive adults on stable antiretroviral therapy will receive chidamide (to reactivate dormant virus) followed by infusions of engineered NK cells designed to kill the reactivated cells. The main goal is to check safety, but researchers will also look for signs that the viral reservoir is shrinking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chidamide combined with NKG2D CAR-NK cells
- What this could lead to
- If it works, this could point toward a functional cure for HIV, allowing patients to control the virus without lifelong medication.
- What could go wrong
- This is a very early, small trial (20 people) focused on safety. The 'shock and kill' approach has not yet been proven in humans, and there are risks like cytokine release syndrome.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 A participant will be deemed eligible for enrollment only if all of the following criteria are met: 1. Diagnosis of HIV infection, with a current history of highly active antiretroviral therapy (HAART) for a minimum duration of two years. 2. Age between 18 and 65 years, inclusive. 3. Plasma HIV RNA level \< 50 copies/mL (virologic suppression). 4. CD4⁺ T cell count \> 200 cells/μL. 5. Adequate hematologic function defined as: * Hemoglobin ≥ 90 g/L; * Platelet count ≥ 75 × 10⁹/L; * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; * White blood cell count ≥ 2 × 10⁹/L. 6. Adequate hepatic and renal function defined as: * Serum creatinine ≤ 1.5 × upper limit of normal (ULN); * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; * Total bilirubin ≤ 2 × ULN; * Prothrombin time (PT) prolongation \< 3 seconds. 7. Hemodynamically stable with a left ventricular ejection fraction (LVEF) ≥ 45%. 8. Negative serum or urine pregnancy test for females of childbearing potential. 9. Willingness of the participant to: * Practice effective contraception during the study period and for one year following completion of the trial; * Voluntarily provide written informed consent and comply with scheduled follow up visits and study procedures. Exclusion Criteria Participants meeting any of the following criteria will be excluded from study participation: 1. Presence of severe cardiovascular, respiratory, or hematologic disease; active infectious disease (other than controlled HIV infection); or active malignancy. 2. Positive serology for hepatitis B surface antigen (HBsAg) or detectable hepatitis C virus RNA (HCV RNA). 3. Diagnosis of chronic kidney disease (CKD). 4. History or presence of acute or chronic pancreatitis. 5. Active severe peptic ulcer disease. 6. Current severe neurologic or psychiatric disorder. 7. History of alcohol abuse or illicit substance use disorder. 8. Known allergic diathesis or hypersensitivity to any component of the investigational agents. 9. Female participants who are pregnant, lactating, or of childbearing potential and unwilling to adhere to required contraceptive measures. 10. Concurrent use of immunosuppressive agents. 11. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for study participation.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the first affiliated hospital of Zhejiang university school of medicine, Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, 310000, China
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