BridgeMD
New treatment option for Hiv
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?
Efavirenz 600mg is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for hiv.
Also referred to as Sustiva, Teva-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
- Antiretroviral therapy or ART blocks HIV replication reducing plasma viral loads to undetectable levels but has no effect on persistently infected cells in the body, called the virus reservoir. These cells carry infectious HIV capable of restarting HIV replication if therapy is stopped.
- 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
- for participants are:
- 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
You likely can't join if
- There will be no exclusion criteria based on gender/gender identity, ethnoracial composition, language, socioeconomic status, mode of HIV acquisition...
- 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
See the full eligibility criteria
- for participants are:
- 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
- Good general health as shown by medical history and screening laboratory tests at the screening visit:
- 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
- There will be no exclusion criteria based on gender/gender identity, ethnoracial composition, language, socioeconomic status, mode of HIV acquisition or sexual orientation/identity. Any participant who requires language...
- 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
- Participants with any of the following abnormal laboratory results at the screening visit:
- 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; topical or ophthalmic corticosteroids for...
- 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's taking place
- 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 - 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?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.