The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine

NCT05536466 | Unknown

• 1 other identifier: LABRADOR
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections; Bariatric Surgery Candidate

Keywords

doravirine; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• AUC of doravirine

  area under the curve, doravirine

  24 hours

Secondary Outcomes (2)

• adverse events

  24 weeks

• HIV viral load

  24 weeks

Study Arms (1)

doravirine treatment

EXPERIMENTAL

patients stable on doravirine and candidate for bariatric surgery

Procedure: bariatric surgery

Interventions

bariatric surgery PROCEDURE

bariatric surgery

doravirine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Leena Zino

CONTACT

0031243611111; leena.zino@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 30, 2022
• Primary Completion: July 23, 2023
• Study Completion: August 1, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share