Could HIV drugs help fight brain cancer? new trial launches
NCT ID NCT06428045
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a combination of antiretroviral drugs (normally used for HIV) and a laser procedure to treat high-grade gliomas—aggressive brain tumors that cannot be surgically removed. About 24 adults with newly diagnosed tumors will receive the laser treatment followed by daily antiretroviral pills. The main goals are to check safety and see if the tumors respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abacavir, Lamivudine, and Ritonavir (antiretroviral drugs) combined with MR-guided laser interstitial thermal therapy (LITT)
- What this could lead to
- If this works, it could point toward a new treatment option for high-grade gliomas that cannot be surgically removed, potentially slowing tumor growth.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, focused mainly on safety. The combination may cause serious side effects, and it is too soon to know if it will effectively control the disease.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2030
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 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: 1. Age ≥ 18 years. 2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI. a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1). 3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon. 4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists. 5. Preoperative Karnofsky score ≥ 70 (APPENDIX A). 6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery. 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 2. Platelets ≥ 100,000 cells/mm3 3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable. 4. Blood urea nitrogen (BUN) ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate \> 50 mL per minute. 5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia. 6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4 7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN). 8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable. 7. Patients must be able to understand and sign informed consent. Exclusion Criteria: 1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7). 2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1). 3. Patients with a previous history of HIV infection. 4. Patients with uncontrolled hepatitis B or C infection. 5. Patients who have received any surgical resection for this tumor. a. Patients who have received an open biopsy for this disease are still eligible for participation. 6. Patients who have received chemotherapy or radiation for this disease. 7. Patients who are taking dofetilide (Section 4.10.1). 8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10. 9. Patients not eligible to obtain MRI with and without contrast. 10. Recurrent HGG. 11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia. 12. Fever within 48 hours of surgery (Temperature\> 38.0°C). 13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician. 14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy. 15. Pregnant women. 16. Patients must be willing to use contraception as described in Section 4.11. 17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial. 18. Prisoners. 19. Adults unable to consent.
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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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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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