Efavirenz (EFV) Intensification

NCT07193875 | Completed Phase 4 FDA Drug

• 1 other identifier: 202210153
• Study Type: interventional
• Target: 7
• 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 (1)

• Safety of Efavirenz intensification on a baseline cART regimen

  Safety of Efavirenz intensification on a baseline cART regimen The safety will be addressed both with laboratory tests (CBC, CMP, CD4, HIV VL) performed monthly, and PHQ9 surveys (for the rare reported adverse effect of worsening depression with Efavirenz) in addition to asking patients more subjective questions of how they are feeling and tolerating the medications and self reporting of (rash, pruritis, mood changes, nausea, vomiting or new abnormal symptoms).

  3 months post completion of trial

Secondary Outcomes (1)

• Size of the latent reservoir

  within 2 years post study completion

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 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 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.

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)

• Barnthouse LW. Issues in ecological risk assessment: the CRAM perspective. Risk Anal. 1994 Jun;14(3):251-6. doi: 10.1111/j.1539-6924.1994.tb00239.x.

  PMID: 8029496 BACKGROUND

MeSH Terms

Interventions

efavirenz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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: September 26, 2025

Record last verified: 2023-01

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)