Status:
COMPLETED
Efavirenz (EFV) Intensification
Lead Sponsor:
Washington University School of Medicine
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 w...
Detailed Description
To evaluate the safety and tolerability of efavirenz (EFV) intensification on the HIV-1 reservoir. Participants with well controlled HIV, specifically with a HIV VL \<500 for at least 48 weeks will be...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Diagnosis of HIV
- Documentation of at least two historical HIV-1 RNA 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
- Untreated depression, defined as a PHQ-9 \> 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.
- Those with active Hepatitis C or Hepatitis B.
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT07193875
Start Date
February 9 2023
End Date
December 16 2024
Last Update
September 26 2025
Active Locations (1)
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1
Washington University in St Louis
St Louis, Missouri, United States, 63110