Status:
COMPLETED
Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV
Lead Sponsor:
Swiss Tropical & Public Health Institute
Collaborating Sponsors:
University Hospital, Basel, Switzerland
University of Basel
Conditions:
HIV
Eligibility:
All Genders
Up to 18 years
Brief Summary
Dolutegravir-based antiretroviral therapy is set to be increasingly replace ritonavir-boosted lopinavir-based regimens for the treatment of paediatric HIV. This prospective cohort study aims to compar...
Detailed Description
Dolutegravir, an antiretroviral drug to treat HIV, has recently been rolled out on a large scale across much of Africa. With paediatric formulations becoming increasingly available, dolutegravir is se...
Eligibility Criteria
Inclusion
- Inclusion Criteria - general:
- Currently taking ritonavir-boosted lopinavir-containing antiretroviral therapy
- Eligible for dolutegravir-based antiretroviral therapy as per national roll-out/guidelines
- Age \< 18 years
- Informed consent (as per consenting procedures)
- Exclusion Criteria - general:
- No transition to dolutegravir-based antiretroviral therapy foreseen
- Already enrolled in another study judged as non-compatible by the Principal Investigator or Local Principal Investigator
- Inclusion Criteria - actigraphy:
- Enrolled into main cohort
- Age ≥6 and \<18 years
- Taking ritonavir-boosted lopinavir-containing antiretroviral therapy for at least 12 weeks
- Last viral load \<50 copies/mL and taken within \<36 weeks and while taking ritonavir-boosted lopinavir-containing antiretroviral therapy
- Willingness to wear an actimetry sensor every night for at least 7 nights (daytime wearing optional)
- Patient and/or caregiver judged to be able to fulfil requirements (wearing actimetry sensor; filling in sleep diary) by study team member conducting screening
- Stated ability to attend all study visits
- Informed consent (as per consenting procedures)
- Exclusion Criteria - actigraphy:
- Intention to transfer out of the study site (and not into a different study site) within 6 weeks
- No actimetry sensor available
Exclusion
Key Trial Info
Start Date :
July 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT05426421
Start Date
July 11 2022
End Date
September 20 2023
Last Update
January 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Center of Excellence Maseru
Maseru, Lesotho