Efavirenz (EFV) Intensification

NCT07193875 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 202210153
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 with HIV (PLWH). The main questions this study aims to address are:

1. 1.is the addition of EFV to a cART regimen safe and well tolerated?
2. 2.Is there a reduction in the blood and tissue HIV reservoir after intensification?

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Safety as Measured by Adverse Events

  Safety as measured by number of serious adverse events, adverse events leading to study discontinuation or adverse events considered clinically significant

  From time of enrollment until completion of study on average 5 months

• Size of the Latent Reservoir (Cluster of Differentiation 4 (CD4) Cells With Intact Provirus/Million CD4 T Cells)

  Size of intact provirus pre and post Efavirenz intensification as measured by IPDA. (CD4 cells with intact provirus/million CD4T cells) Time frame: IPDA (CD4 T cells carrying intact HIV provirus per million total CD4 T cells) at least of two time points (1) at study enrolment and (2) 4 months post EFV intensification

  (1) at study enrolment and (2) 4 months post EFV intensification

Study Arms (1)

Efavirenz intensification

OTHER

There is only one arm in this study

Drug: Efavirenz 600mg

Interventions

Efavirenz 600mg DRUG

Take One pill daily for 6 months in addition to baseline combination antiretroviral therapy regimen

Efavirenz intensification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Those with active Hepatitis C or Hepatitis B.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Wang Q, Gao H, Clark KM, Mugisha CS, Davis K, Tang JP, Harlan GH, DeSelm CJ, Presti RM, Kutluay SB, Shan L. CARD8 is an inflammasome sensor for HIV-1 protease activity. Science. 2021 Mar 19;371(6535):eabe1707. doi: 10.1126/science.abe1707. Epub 2021 Feb 4.

  PMID: 33542150 BACKGROUND

MeSH Terms

Interventions

efavirenz

Results Point of Contact

• Title: Priya Pal
• Organization: Washington University in St Louis

idcru@wustl.edu

314-454-0058

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be their own control for size of latent reservoir. We will compare each person's reservoir before and after addition of Efavirenz.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 26, 2025
• Study Start: February 9, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: within 3 years of study completion
• Access Criteria: depends on the journal the study results are published in

Locations

US (1)