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NCT05637879PHASE2, PHASE3Recruiting

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

White River Junction Veterans Affairs Medical Center

Start Date

12/18/2023

Completion Date

9/30/2026

Summary

A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).

Detailed Description

N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE/PIB for PTSD symptom improvement in the absence of HCV. Primary Aims: Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for functioning improvement among patients with PTSD. Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.

Eligibility Criteria

Age Range: 19 years to 70 years

Inclusion Criteria: 1. Age 19-70 years 2. Weight ≥ 45 kg 3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment 4. Eligible for Veterans Affairs healthcare 5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required. 6. Able to read, understand, and sign the informed consent document. Exclusion (unable to participate) Criteria: 1. Pregnant or lactating person 2. Moderate or severe hepatic impairment (Child-Pugh B or C) 3. History of prior hepatic decompensation 4. Current use of drugs listed as having significant drug interactions on prescribing label 5. Advanced liver disease 6. Current or prior hepatitis B infection 7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor 8. Current HCV infection 9. Current psychosis or mania 10. Significant suicidal ideation 11. Unstable medical conditions 12. Current severe alcohol or substance use disorder (excluding nicotine) 13. Evidence-based PTSD psychotherapy changes in the past two months 14. Evidence-based PTSD medication changes in the past two months

Interventions

DRUG

Glecaprevir/pibrentasvir

OTHER

Placebo

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Conditions

PTSD

Locations

White River Junction VAMC

White River Junction, Vermont 05001

United States