Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV

NCT05426421 | Completed

• 4 other identifiers: P001-22-1.0ID37-2022H-514723ZX1422
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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 compare tolerability, adverse effects, and virological outcomes between the two regimen types using a before-after design. The study is conducted in Lesotho, southern Africa, and includes children and adolescents transitioning from ritonavir-boosted lopinavir-based to dolutegravir-based antiretroviral therapy. It aims to provide detailed information on treatment tolerability and to inform paediatric treatment programmes.

Conditions

HIV

Keywords

dolutegravir; lopinavir; children; adolescents; paediatric; adverse effects; tolerability; treatment satisfaction; insomnia; sleep; gastrointestinal; depression; human immunodeficiency virus; cohort

Outcome Measures

Primary Outcomes (2)

• Sleep duration during monitoring period 3 (2-4 weeks post-transition) versus monitoring period 1 (0-2 weeks pre-transition)

  Sleep will be monitored using actigraphy sensors for a subset of participants. There will be three sleep monitoring periods: 0-2 weeks before transition from ritonavir-boosted lopinavir- to dolutegravir-based antiretroviral therapy (period 1), 0-2 weeks after transition, and 2-4 weeks after transition). We will conduct a before-after analysis.

  [2-4 weeks post-transition] vs [0-2 weeks pre-transition]

• Change in treatment satisfaction, assessed using the HIV Treatment Satisfaction Questionnaire (HIVTSQ) change version (HIVTSQ-c)

  10-item scale with each item scored from -3 to +3 (overall range -30 to +30), with higher scores indicating increases in treatment satisfaction

  4 weeks post-transition

Secondary Outcomes (9)

• Viral suppression rate among those with virological data

  6 months, 12 months, and 24 months after transition

• Engagement in care with viral suppression

  6 months, 12 months, and 24 months after transition

• Sleep duration during monitoring period 2 (0-2 weeks post-transition) versus monitoring period 1 (0-2 weeks pre-transition)

  [0-2 weeks post-transition] vs [0-2 weeks pre-transition]

• Sleep fragmentation

  [2-4 weeks post-transition] vs [0-2 weeks pre-transition], and [0-2 weeks post-transition] vs [0-2 weeks pre-transition]

• Treatment satisfaction after vs before transition, assessed using the HIVTSQ status version (HIVTSQ-s)

  4 weeks post-transition vs at transition

Other Outcomes (2)

• Proportion of participants with drug resistance among participants with viraemia while taking dolutegravir

  until 24 months after transition

• Impact of drug resistance at time of transition on subsequent viral suppression

  until 24 months after transition

Study Arms (2)

No actigraphy

Participants will receive viral load testing at transition from LPV/r-based to DTG-based ART, and subsequent routine viral load data will be analysed. Questionnaires will be filled in and dried blood spots collected at transition and at four weeks. Medical history as well as clinical and socio-demographic data will be collected.

With actigraphy

Participants will receive viral load testing at transition from LPV/r-based to DTG-based ART, and subsequent routine viral load data will be analysed. Baseline actigraphy data will be collected for two weeks prior to transition (actigraphy period 1), and for four weeks after transition (actigraphy period 2 from 0-2 weeks after transition; actigraphy period 3 from 2-4 weeks after transition). Sleep diaries will be filled in during all actigraphy periods. Questionnaires will be filled in and dried blood spots taken at transition as well as two and four weeks after transition. Medical history as well as clinical and socio-demographic data will be collected.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents living with HIV, receiving treatment, and transitioning from ritonavir-boosted lopinavir-based to dolutegravir-based antiretroviral therapy in the context of the national rollout of dolutegravir.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)
• Intention to transfer out of the study site (and not into a different study site) within 6 weeks
• No actimetry sensor available

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• University Hospital, Basel, Switzerland: collaborator
• University of Basel: collaborator
• University of Zurich: collaborator
• Baylor International Pediatric AIDS Initiative: collaborator
• Lesotho Ministry of Health: collaborator
• Baylor College of Medicine Children's Foundation Lesotho: collaborator

Study Sites (1)

Baylor Center of Excellence Maseru

Maseru, Lesotho

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer Brown, PhD

  University of Basel

  PRINCIPAL INVESTIGATOR

• Akash Devendra, MBChB

  Baylor International Paediatric AIDS Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 22, 2022
• Study Start: July 11, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)