HIV InfectionsLABRADORNCT05536466
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
A study testing bariatric surgery in people with HIV Infections and Bariatric Surgery Candidate, run by Radboud University Medical Center.
Trial summary
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Bariatric Surgery Candidate
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected
- VL suppressed <40c/ml for at least 6 months, blips are allowed
- planned to have bariatric surgery (gastric bypass or gastric sleeve)
- Able to sign informed consent
- Age > or equal to 18 years
- Using doravirine for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery
Who cannot join
- 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 doravirine
- Creatinine clearance <40 ml/min
- Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
- Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.
Trial locations and contacts
No sites are listed yet.
About this study
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.
- Conditions
- HIV Infections, Bariatric Surgery Candidate
- Being tested
- bariatric surgery
- Keywords
- doravirine, pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| doravirine treatment | Experimental | patients stable on doravirine and candidate for bariatric surgery Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of doravirine
area under the curve, doravirine
Measured: 24 hours
Secondary outcomes (2)
adverse events
adverse events
Measured: 24 weeks
HIV viral load
HIV viral load
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion23 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536466
- Sponsor's protocol ID
- LABRADOR
- Acronym
- LABRADOR
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
- ClinicalTrials.gov ID
- NCT05536466
- Acronym / sponsor ID
- LABRADOR / LABRADOR
- Conditions
- HIV Infections, Bariatric Surgery Candidate
- Keywords
- doravirine, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 23 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
| Arm | Type | Receives |
|---|---|---|
| doravirine treatment | Experimental | Procedure: bariatric surgerypatients stable on doravirine and candidate for bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-infected
- VL suppressed <40c/ml for at least 6 months, blips are allowed
- planned to have bariatric surgery (gastric bypass or gastric sleeve)
- Able to sign informed consent
- Age > or equal to 18 years
Key exclusion criteria (6 listed)
- 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 doravirine
- Creatinine clearance <40 ml/min
- Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgerybariatric surgery | Procedure or surgery | doravirine treatment |
Primary outcome
AUC of doravirine
Time frame: 24 hours
area under the curve, doravirine
2 secondary outcomes
adverse events
Time frame: 24 weeks
HIV viral load
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric surgery in people with HIV Infections and Bariatric Surgery Candidate, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leena Zino (0031243611111, leena.zino@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of doravirine (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.