Letermovir in ART-treated HIV-infected Persons

Korábbi kezelés

• Current participation in an experimental therapy study or receipt of experimental therapy within the last 6 months.

Más betegség

• Current AIDS-related event or serious health condition including systemic infections in the last 3 months.
• Severe systemic diseases (e.g. uncontrolled hypertension, chronic renal failure), or active uncontrolled infections including Coronavirus disease 19 (COVID-19) (as tested by PCR).
• Co-infection with active Hepatitis B or C Virus. Current use or have used in the past 3 months: immune-modulatory agents, prophylactic antibiotics, proton pump inhibitors, Metformin or Morphine as these drugs modulate inflammation and/or gut microbiota composition.
• Current use of any drug with known drug-on-drug interaction with letermovir, as described in the PREVYMIS® (letermovir tablets) Product Monograph, including pimozide, ergot alkaloids, cyclosporine concomitantly administered with lovastatin, rosuvastatin, simvastatin or bosentan. For patients not using cyclosporine, dose of statins will be reduced by 50% for the duration of the study as a precaution, which is not expected to increase cardiovascular risk. Regarding HIV medication, exclusionary agents include darunavir, efavirenz, etravirine and nevirapine.
• Psychiatric or cognitive disturbance or any illness that could preclude compliance with the study.
• Patients with moderate hepatic impairment combined with moderate or severe renal impairment (CrCl less than 50 mL/min)

Egyéb

• Patients who are hypersensitive to letermovir or to any ingredient in the formulation of PREVYMIS®, including any non-medicinal ingredient, or component of the container.
• Recent changes in dietary habits, intermittent fasting, chronic constipation or laxative use as these can affect gut microbiota.
• Women who are planning to become or who are pregnant, or breast-feeding. A score of higher than 8 on a Full AUDIT questionnaire at the screening visit, suggesting an alcohol abuse problem.

• Participants will be eligible for the study if they meet the following criteria:
• Male or female adults ≥18 years of age.
• Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay.
• CMV seropositive (as per clinical lab test).
• On ART for at least 3 years, and stable ART regimen (same prescription) for at least 3 months.
• Undetectable viral load < 50 copies/ml for the past 3 years. Viral blips in the past 3 years, below 200 copies/ml, are allowed if preceded and followed by a HIV viremia below 50 copies/ml.
• CD4 count >400 cells/µL of blood
• Able to communicate adequately in either French or English.
• Able to understand and willing to provide written informed consent prior to screening.
• Women of childbearing potential must have a negative serum pregnancy test.
• Women of childbearing potential must agree to use one of the following approved methods of birth control while in the study and until 2 weeks after completion of the study:
  • Complete abstinence from penile-vaginal intercourse from the screening period until 2 weeks after study completion.
  • Double barrier method (acceptable barrier methods include diaphragm, coil, contraceptive foam, sponge with spermicide, or condom).
  • Oral, injectable or implant contraceptives, started at least 30 days before screening, plus one barrier method.
  • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion) plus one barrier method.
  • Male partner sterilization confirmed prior to the female participant's entry into the study; this male is the sole partner for that participant.
  • Another method approved by the Investigator with published data showing that the expected failure rate is <1% per year preferably with one barrier method.
  • Any contraception method must be used consistently, in accordance with the approved product label, and for the duration of the study until two weeks after study completion.
• Women of non-child-bearing potential as defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
• Sexually active men with a female partner of childbearing potential must agree to one of the following methods of birth control:
  • The use of at least one barrier method of contraception (e.g. condom) with a female partner using a second approved method of contraception (IUD, hormonal contraceptive pill, diaphragm, spermicide, etc.) during the study and until two weeks after study completion.
  • Have had a successful vasectomy. Be confirmed sterile.