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Herbal formula may help HIV patients whose immune systems Don't fully recover

NCT ID NCT07698574

Disease control Sponsor: Beijing University of Chinese Medicine 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether adding Qiling Yiqi tablets, a Chinese herbal medicine, to standard HIV therapy can improve immune function in people whose CD4 counts remain low despite successful viral suppression. The trial involves 240 adults with HIV who have been on antiretroviral therapy for years but still have weak immune systems. Participants will take the herbal tablets or a placebo for 48 weeks, and researchers will measure changes in CD4 cell counts and other immune markers.

What this could mean

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

Active substance
Qiling Yiqi Tablets (a Chinese herbal formula containing Astragalus, Codonopsis, and other herbs)
What this could lead to
If successful, this could offer a new option to help people with HIV rebuild their immune system when standard therapy alone is not enough.
What could go wrong
This is a relatively small, early-stage trial. The herbal tablets may not improve immune function, and there could be side effects or interactions with HIV medications.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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 60 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:Aged 18 to 60 years, male or female. CD4+ T lymphocyte count \<350 cells/uL. Meets diagnostic criteria for HIV-1 infection according to the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS (2024 edition). Meets diagnostic criteria for incomplete immune reconstitution: ART for more than 4 years; peripheral blood viral load below the lower limit of detection (\<50 copies/mL) for more than 3 years; persistent CD4+ T-cell count \<350 cells/uL; and exclusion of other causes of long-term low CD4+ T-cell count. Meets the Traditional Chinese Medicine diagnostic criteria for lung-spleen qi deficiency syndrome, supported by the designated four-diagnostic instrument (model SZY-ZM-1) where applicable. Voluntarily agrees to participate and signs informed consent. - Exclusion Criteria:Uncontrolled acute or chronic physical or mental illness. Poor adherence to ART. WBC \<2 x 10\^9/L, neutrophils \<1.0 x 10\^9/L, hemoglobin \<90 g/L, platelets \<75 x 10\^9/L, or abnormal hepatic/renal function. Hepatic abnormality is defined as AST, ALT, or total bilirubin \>=2 times the upper limit of normal; renal abnormality is defined as creatinine clearance below the normal value. Other serious comorbid disease, such as tumor, cirrhosis, or cardiovascular/cerebrovascular disease. Pregnancy, lactation, or recent plan for pregnancy/childbearing. Use of immunosuppressants or immunomodulators within 6 months before screening. Any other condition judged by the investigator to make the participant unsuitable for the study. \-

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

Acquired immunodeficiency syndrome HIV-1-infection Immune reconstitution failure Immunological non-responder Lung-spleen qi deficiency syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing University of Traditional Chinese Medicine

    Beijing, Beijing Municipality, 100029, China

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