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Efavirenz (EFV) Intensification

NCT07193875

CompletedPhase 4

Sponsor: Washington University School of Medicine

Conditions: HIV

Interventions: Efavirenz 600mg

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. At least 18 years of age
2. Diagnosis of HIV
3. Documentation of at least two historical HIV-1 RNA viral load measurements \<500 copies/mL while on ART obtained by standard assay.
4. No known non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations.
5. 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:

1. Untreated depression, defined as a Patient health questionnaire 9 (PHQ-9) score \> 15 at time of enrollment
2. Known prior NNRTI resistance, or INSTI resistance.
3. Cytochrome 450 polymorphism resulting in rapid or delayed metabolism of Efavirenz
4. Not currently on a PI based regimen.
5. Does not have an immunocompromising medical condition. (ie malignancies particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment).
6. Chronic, acute, or recurrent infections that are current and serious, in the opinion of the site investigator.
7. Breastfeeding patients as well as those whom are pregnant or plan to become pregnant during period of the study.
8. Those with active Hepatitis C or Hepatitis B.

Locations (1)

St Louis, Missouri, United States