Can fewer HIV drugs keep the virus just as suppressed?
NCT ID NCT04553081
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether switching from a standard three-drug HIV regimen to a two-drug regimen keeps the virus under control just as well. The trial enrolls 134 adults whose HIV is already suppressed on a three-drug regimen and randomly assigns them to continue that regimen or switch to a two-drug combination. Over 48 weeks, researchers measure intact, replication-competent HIV in immune cells, along with inflammation markers and immune function, to see whether the two-drug approach is a safe long-term alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two-drug HIV regimen (dolutegravir plus lamivudine) compared with a three-drug regimen (bictegravir, tenofovir alafenamide, emtricitabine)
- What this could lead to
- If the two-drug regimen matches the three-drug regimen, people with HIV could control the virus with fewer medicines and less long-term drug exposure.
- What could go wrong
- The trial may find the two-drug regimen leaves more intact virus or more inflammation than the three-drug regimen. The 48-week main comparison is relatively short for a lifelong infection, and 134 participants is a modest sample.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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134 people
The number who actually took part.
- Started
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May 2020
- Finished
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Mar 2026
- 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 years and older
- 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: * Age = or \>18 years. * Ability and willingness to provide written informed consent. * Ability to attend the complete schedule of assessments and patient visits. * Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes. * HIV RNA \< 50 copies/mL for at least 3 months on a 2nd generation INSTI based regimen. * Females of childbearing potential should be on effective contraception Exclusion Criteria: * Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification). * Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (seroconversion= HBV antigen or viral load negative and positive HBV surface antibody). * Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry. * Pregnancy or breastfeeding. * Patients unable to understand the study protocol or any other condition that in the investigator's opinion may compromise compliance with the study protocol * Decompensated liver cirrhosis (Child-Pugh B/C) * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones) * Psychiatric and psychological disorders, which in the opinion of the investigator, will interfere with the trial conduct or safety of the participant. * Previous participation in a trial evaluating an immune modulating agent. * Active drug or alcohol use/addiction such that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance * Creatinine Clearance \<50 * Tuberculosis treatment * Documented M184V * Previous virological failure \>200 copies/mL on NRTI * Subjects with history or presence of allergy to any of the study drugs or their components * ALT \>5 times the ULN, OR ALT \>3xULN and bilirubin \>1.5xULN (with \>35% direct bilirubin)
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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
-
Ghent University Hospital
Ghent, 9000, Belgium
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