Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)
- Conditions
- HIV-infected Participants With ESRD Undergoing Routine Hemodialysis
- Registration Number
- NCT04689737
- Lead Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria:<br><br> 1. Males and females* aging = 18 years.<br><br> 2. Documented HIV infection).<br><br> 3. Stable antiretroviral treatment for at least 2 weeks prior to enrolment.<br><br> 4. Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses<br> within the previousweek.<br><br> 5. End-stage renal disease in renal replacement therapy with periodic hemodialysis.<br><br> 6. Agree with the study procedures and signature of the informed consent. *Women of<br> childbearing potential must have a negative pregnancy test prior to randomization<br> into the study and commitment to useat least one of these birth control methods:<br> male or female condom with or without spermicide, cap, diaphragm or sponge with<br> orwithout spermicide, intrauterine device, bilateral tubal occlusion, vasectomized<br> partner, sexual abstinence during the study. Condomuse is considered as an<br> additional method of contraception only and cannot be the only method of<br> contraception used as not beenconsidered an effective method by the Clinical Trial<br> Facilitation Group (CTFG) guidelines.<br><br>Based on ICH, M3 (R2) 2009 a woman is considered of childbearing potential: fertile,<br>following menarche and until becoming post-menopausal unless permanently sterile.<br>Permanent sterilization methods include tubal ligation, hysterectomy, bilateral<br>oophorectomy.<br><br>Exclusion Criteria:<br><br> 1. Evidence or clinical suspicion that the patient will not be able to comply with the<br> study protocol.<br><br> 2. Hypersensitivity to doravirine<br><br> 3. Concomitant therapy within the previous 4 weeks with any of the following drugs:<br><br> - Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin<br><br> - Androgen receptor inhibitor: enzalutamide<br><br> - Antimycobacterials: rifampin, rifapentine<br><br> - Cytotoxic agent: mitotane<br><br> - St. John's wort (Hypericum perforatum)<br><br> 4. Females who are pregnant or breastfeeding.<br><br> 5. ALT and/ or AST = 4 times the upper limit of normal (ULN) at screening.<br><br> 6. Hemoglobin < 7,5 g/dL at screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentatge of Doravirine Dialysis Extraction Ratio (ER)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Developing Related Adverse Events Grade 3-4 Related to Doravirine;Doravirine Concentration (mg/dl)