The influence of having bariatric surgery on the pharmacokinetics, safety and efficacy of the novel non-nucleoside reverse transcriptase inhibitor doravirine (LABRADOR)

Phase 4

Completed

Conditions: obesitas
HIV-infection
obesity-surgery
10047438
10017998

Registration Number: NL-OMON51582

Lead Sponsor: Afdeling Apotheek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

- hiv-infected
- Viral load suppressed , below 40 copy/ml for at least 6 months, blips are
allowed
- 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate the influence of BS on the pharmacokinetics of DOR in HIV<br /><br>patients represented by Geometric mean ratios (GMR) with 90% confidence<br /><br>interval (CI) of PK parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The percentage of patients showing a HIV VL >40 copy/ml will be reported.<br /><br>Descriptive analysis will be provided for CD4 count pre- and post-BS as well as<br /><br>safety data post-BS</p><br>