NCT07193875CompletedPhase 4
Efavirenz (EFV) Intensification
Safety, Tolerability, and Efficacy of Efavirenz (EFV) Intensification on HIV-1 Reservoir Reduction
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 16 Sept 2025
- Start date
- 9 Feb 2023
- Primary completion date
- 16 Dec 2024
- Lead sponsor
- Washington University School of Medicine
- Diseases
- HIV
- NCT number
- NCT07193875
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 9
- From 9 Feb 2023 to the primary completion date, 16 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known prior NNRTI resistance, or INSTI resistance.
- Not currently on a PI based regimen.
Other illness
- 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.
- Those with active Hepatitis C or Hepatitis B.
Other
- Untreated depression, defined as a Patient health questionnaire 9 (PHQ-9) score \> 15 at time of enrollment
- Cytochrome 450 polymorphism resulting in rapid or delayed metabolism of Efavirenz
- Breastfeeding patients as well as those whom are pregnant or plan to become pregnant during period of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.