Exposure to Doravirine in people with HIV undergoing weight loss surgery
- Conditions
- HIV 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]
- Registration Number
- EUCTR2021-005347-79-NL
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8
-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
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method