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Completed
NCT07193875
Efavirenz (EFV) Intensification
Conditions: HIV
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 9
Sponsor: Washington University School of Medicine
Location: Washington University in St Louis St Louis Missouri
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. 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 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 \ 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.
Source: ClinicalTrials.gov (NCT07193875). StuddyBuddy aggregates publicly available trial information.