Hiv study: Efavirenz
Official title The T Cell Activator of Cell Killing ("TACK") IT ON" STUDY
ClinicalTrials.gov ID: NCT06823596
What this study is testing
What is Efavirenz 600mg?
An investigational oral medication being studied to reduce residual HIV viremia in people on stable antiretroviral therapy. is designed to activate the CARD8 inflammasome, leading to pyroptosis of HIV‑infected cells.
Also referred to as Sustiva, Teva‑Efavirenz, Mylan‑Efavirenz, Jamp‑Efavirenz, Auro‑Efavirenz.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if Efavirenz can kill HIV‑infected cells and reduce the small amount of virus that remains in the blood of people on treatment.
- Who it's for
- Adults with HIV who are on antiretroviral therapy but still have low‑level virus in their blood.
- What's involved
- Participants will take Efavirenz in addition to their current medication and will have regular blood tests and clinic visits to monitor virus levels and safety.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Ability to provide signed written informed consent; age \>18 years
- Documented HIV diagnosis
- Continuous antiretroviral therapy for \> 4 years with no issues of adherence
- Taking a stable ART regimen, without the inclusion of a protease inhibitor
- At least 4 HIV viral loads \>20 and \< 400 copies/ml over the past two years
You likely can't join if
- Participants who would have difficulty participating in a trial due to non-compliance
- No active medications / illicit drugs that could adversely affect study compliance
- Currently prescribed and using EFV as part of ongoing ART treatment regimen for HIV suppression
- Currently prescribed a protease inhibitor or pharmacologic booster (cobisistat) as part of current ART regimen
- History of major psychiatric condition that would be adversely affected by efavirenz
- Diagnosed severe cognitive impairment or of strong concern in the judgement of investigators that efavirenz would adversely affect participant
See the full eligibility criteria
- Ability to provide signed written informed consent; age \>18 years
- Documented HIV diagnosis
- Continuous antiretroviral therapy for \> 4 years with no issues of adherence
- Taking a stable ART regimen, without the inclusion of a protease inhibitor
- At least 4 HIV viral loads \>20 and \< 400 copies/ml over the past two years
- No documented resistance to EFV in history, no PI including ritonavir in current ART regimen or during study period
- No evidence of EFV resistance by plasma virus sequencing at screening visit
- Non-pregnant throughout the study period, if female sex
- Hemoglobin ≥ 85 g/L, white blood cell count (WBC) \> 3,000 cells/mm3
- Total lymphocyte count .750 X109/L
- Platelets = 50 to 550 X109/L
- Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase \< 5 times the institutional upper limit of normal (ULN);
- Willing to undergo either leukapheresis or blood draw at visits 2 and 7 (participants will be given the option to undergo blood draws rather than leukapheresis)
- Ability to add efavirenz to their current ART HIV medication re: avoid drug to drug interactions
- Participants who would have difficulty participating in a trial due to non-compliance
- No active medications / illicit drugs that could adversely affect study compliance
- Currently prescribed and using EFV as part of ongoing ART treatment regimen for HIV suppression
- Currently prescribed a protease inhibitor or pharmacologic booster (cobisistat) as part of current ART regimen
- History of major psychiatric condition that would be adversely affected by efavirenz
- Diagnosed severe cognitive impairment or of strong concern in the judgement of investigators that efavirenz would adversely affect participant
- Documented or suspected history of resistance to any NNRTI including efavirenz, nevirapine or rilpivirine
- History of severe intolerance or documented allergy to efavirenz
- Hemoglobin \< 85 g/L
- Lymphocyte count \< .750 X109/L
- Platelet count \ 550 X109/L
- AST or ALT \> 5X the upper limit of normal
- Creatinine \> 250 µmol/L
- Participants with a malignancy or undergoing chemotherapy
- Participants with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
- Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis
- Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints
- Any other conditions judged by the investigator that would limit the evaluation of a participant
- Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the...
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.