The goal of this clinical trial is to see if Efavirenz (EFV) intensification to a baseline combination antiretroviral regimen (cART) can help reduce the size of the latent reservoir in people living with HIV (PLWH). The main questions this study aims to address are:
1. is the addition of EFV to a cART regimen safe and well tolerated?
2. Is there a reduction in the blood and tissue HIV reservoir after intensification?
Researchers will compare each participants reservoir size prior to and post EFV intensification.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age
. Diagnosis of HIV
. Documentation of at least two historical HIV-1 RNA viral load measurements \<500 copies/mL while on ART obtained by standard assay.
. No known non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations.
. Currently on a stable regimen including an integrase strand transfer inhibitor (INSTI) and two nucleoside reverse transcriptase inhibitors (NRTI). Receiving the current regimen for at least 90 days prior to study entry with no intention to change for the duration of the study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety as Measured by Adverse Events
Timeframe: From time of enrollment until completion of study on average 5 months
2
Size of the Latent Reservoir (Cluster of Differentiation 4 (CD4) Cells With Intact Provirus/Million CD4 T Cells)
Timeframe: (1) at study enrolment and (2) 4 months post EFV intensification
. Untreated depression, defined as a Patient health questionnaire 9 (PHQ-9) score \> 15 at time of enrollment
. Known prior NNRTI resistance, or INSTI resistance.
. Cytochrome 450 polymorphism resulting in rapid or delayed metabolism of Efavirenz
. Not currently on a PI based regimen.
. Does not have an immunocompromising medical condition. (ie malignancies particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment).
. Chronic, acute, or recurrent infections that are current and serious, in the opinion of the site investigator.
. Breastfeeding patients as well as those whom are pregnant or plan to become pregnant during period of the study.