Can stronger HIV drug doses flush out the virus that hides?

NCT ID NCT06640192

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

HIV drugs keep the virus in check, but the virus hides in a latent reservoir, mostly in lymph tissue, and that reservoir is the main barrier to a cure. Researchers are testing whether giving three HIV drugs at higher-than-usual doses can push more drug into lymph tissue and reduce the size of that hidden reservoir. The trial enrolls 18 adults with HIV and compares standard triple therapy with high-dose dolutegravir, maraviroc and lamivudine. Researchers measure viral DNA in blood and lymph tissue to see whether the reservoir shrinks.

What this could mean

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

Active substance
a high-dose combination of three HIV drugs: dolutegravir, maraviroc and lamivudine
What this could lead to
If higher drug doses reach hidden virus in lymph tissue and shrink the reservoir, this could point toward a strategy for a durable, treatment-free remission of HIV.
What could go wrong
This is a small phase 2 trial with 18 participants, so any effect may not hold in larger groups. Higher doses may cause more side effects, and shrinking the reservoir does not guarantee the virus stays suppressed without standard treatment.

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.

Participants

18 people

The number who actually took part.

Started

May 2025

Expected to finish

Jun 2027

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: * Patients who, after receiving information about the study design, the aims of the study, the possible risks that may arise from it and the fact that they can refuse to collaborate at any time, give written consent to participate in the study. * Be over 18 years of age and under 60 years of age. * Understand the purpose of the study and be available to perform the visits and procedures established in the protocol. * Persons with HIV being followed up in HIV consultations. * Antiretroviral treatment with a triple regimen containing an integrase inhibitor. * Undetectable plasma viral load (\<50 copies of HIV RNA in blood plasma) for at least 12 months prior to inclusion. * No history of prior virologic failure. * No known gastrointestinal disease. * R5 viral tropism, determined on proviral DNA. * In women: negative urine pregnancy test performed within 7 days prior to the start of study treatment in women of childbearing age and if \< 2 years post menopause. * Women of childbearing age and male partners of childbearing age must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives, or hormonal contraceptive implants) and to continue using them until 6 months after the last dose of treatment. Exclusion Criteria: * Chronic Hepatitis B (HBsAg +) * Untreated chronic hepatitis C * Viral tropism X4 * Pregnancy or planning to become pregnant during the course of the study. * Lactation. * Abnormal coagulation parameters (PT\> or equal to 1.2 LSN). * Thrombocytopenia (platelet count \<50000). * Transaminases in values greater than 3 times normal. * Impaired renal function (plasma creatinine \>1.5 mg/dl, creatinine clearance \<60 ml/min/1.73 m2). * Contraindications for the performance of any of the study procedures (colonoscopy/bowel biopsy) or conscious sedation. * Anemia (greater than or equal to grade 1). * Administration of aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited 1 week before endoscopy. * Concomitant treatment with cytochrome CYP3A inducers or inhibitors. * Patients in whom there is a contraindication for use according to the established in the technical data sheet or known hypersensitivity to the drugs under investigation or who, according to the investigator's criteria, it is not advisable to participate.

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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

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

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