EUCTR2021-005347-79-NL
Active, not recruiting
Phase 1
The influence of having bariatric surgery on the pharmacokinetics, safety and efficacy of the novel non-nucleoside reverse transcriptase inhibitor doravirine (LABRADOR) - LABRADOR
ConditionsHIV plus bariatric surgeryMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862MedDRA version: 21.1Level: LLTClassification code 10068900Term: Bariatric surgerySystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV plus bariatric surgery
- Sponsor
- Radboud University Medical Center
- Enrollment
- 8
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-HIV\-infected
- •\-VL suppressed \<40c/ml for at least 6 months, blips are allowed
- •\-planned to have BS (GBP or SG)
- •\-Able to sign informed consent
- •\-Age \> or equal to 18 years
- •\-Using DOR for at least 4 weeks prior to BS with VL \< 40 copies/mL prior to the surgery
- •7\.Using doravirine for at least 4 weeks prior to bariatric surgery with no detectable viral load
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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 DOR
- •\-Has significant hypersensitivity or other contraindication to DOR
- •\-Creatinine clearance \<40 ml/min
- •\-Severe liver dysfunction (Diagnosed liver cirrhosis: Child\-Pugh C)
- •\-Pregnancy or planning to be pregnant during first 6 months post BS.
Outcomes
Primary Outcomes
Not specified
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