NL-OMON51582
Completed
Phase 4
The influence of having bariatric surgery on the pharmacokinetics, safety and efficacy of the novel non-nucleoside reverse transcriptase inhibitor doravirine (LABRADOR) - LABRADOR
Afdeling Apotheek0 sites1 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Afdeling Apotheek
- Enrollment
- 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- hiv\-infected
- •\- Viral load suppressed , below 40 copy/ml for at least 6 months, blips are
- •\- planned to have bariatric surgery (gastric bypass or Sleeve gastrectomy)
- •\- Able to sign informed consent
- •\- Age above or equal to 18 years
- •\- Using doravirine for at least 4 weeks prior to bariatric surgery with no
- •detectable viral load
Exclusion Criteria
- •\- History or current evidence of any condition, therapy, laboratory abnormality
- •or other circumstance that might confound the results of the study or interfere
- •with the subject\*s participation
- •\- Requires or is anticipated to require any of the prohibited medications known
- •to contradict/interact with doravirine
- •\- Has significant hypersensitivity or other contraindication to DOR
- •\- Creatinine clearance below 40 ml/min
- •\- Severe liver dysfunction (Diagnosed liver cirrhosis: Child\-Pugh C)
- •\- Pregnancy or planning to be pregnant during first 6 months post surgery.
Outcomes
Primary Outcomes
Not specified
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