An observational study in HIV, sponsored by Swiss Tropical & Public Health Institute. Completed at 1 site in Lesotho. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Swiss Tropical & Public Health Institute · Observational
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.
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 set to replace ritonavir-boosted lopinavir as the core agent in paediatric treatment regimens in many countries. While both drugs are well-studied and highly effective, they reportedly differ with regards to their tolerability at least in adults, with ritonavir-boosted lopinavir typically associated with gastrointestinal adverse effects and dolutegravir mostly associated with neuropsychiatric adverse effects including insomnia. Resistance patterns also differ between these two treatment options. However, studies focusing specifically on the tolerability of and adverse effects associated with either drug in children and adolescents are scarce.
This prospective cohort study aims to i) compare treatment satisfaction, health-related quality of life, tolerability, and symptoms or side-effects associated with either drug option, ii) specifically compare sleep outcomes quantified through actigraphy with either drug option, and iii) provide observational evidence on virological outcomes in a resource-limited setting using a before-after design.
The study is conducted at several sites in Lesotho, southern Africa. It enrols children and adolescents \<18 years of age who are taking ritonavir-boosted lopinavir-based therapy at enrolment and routinely due to transition to dolutegravir-based therapy as per the national roll-out plan. On the day of transitioning to dolutegravir as well as four weeks thereafter, participants will complete questionnaires on treatment satisfaction, gastrointestinal symptoms, depressive symptoms, and sleep habits. A subset of participants fulfilling additional inclusion criteria will additionally use actigraphy sensors to monitor sleep duration and sleep fragmentation; these individuals will have study visits two weeks before transition to dolutegravir to initiate actigraphy, at transition, as well as two and four weeks after transition, with questionnaires at all but the pre-transition visit and actigraphy (target: at least seven nights with high-quality data) between all visits. For all participants, medical records will be assessed and additional clinical and sociodemographic data collected. A viral load test will be done on the day of transitioning to dolutegravir, and subsequent routine viral load test results (every six months as per national guidelines) will be assessed. Dried blood spots will be taken at all visits, barring the pre-transition visit for those with actigraphy.
This study aims to inform the continued roll-out of dolutegravir replacing ritonavir-boosted lopinavir in paediatric antiretroviral therapy regimens, notably assessing the suitability of a one-size-fits-all approach and providing detailed information on tolerability and adverse effects of either regimen.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 258 is above the median of 138 across 318 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
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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.
Inclusion Criteria - general:
Exclusion Criteria - general:
Inclusion Criteria - actigraphy:
Exclusion Criteria - actigraphy:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: [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
Time frame: 4 weeks post-transition
Viral suppression rate among those with virological data
Proportion of participants with a viral load \<50 copies/mL among all participants with virological data
Time frame: 6 months, 12 months, and 24 months after transition
Engagement in care with viral suppression
Proportion of participants with a viral load \<50 copies/mL among all participants
Time frame: 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)
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.
Time frame: [0-2 weeks post-transition] vs [0-2 weeks pre-transition]
Sleep fragmentation
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.
Time frame: [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)
10-item scale with each item scored from 0 to 6 (overall range 0 to 60), with higher scores indicating higher treatment satisfaction. Two time points compared in a before-after analysis.
Time frame: 4 weeks post-transition vs at transition
Gastrointestinal symptoms after vs before transition, assessed using the Gastrointestinal Symptom Rating Scale adapted for protease inhibitors (GSRS-PI)
13-item scale with each item scored from 1 to 6, with higher scores indicating greater discomfort. Two time points compared in a before-after analysis.
Time frame: 4 weeks post-transition vs at transition
Depressive symptoms after vs before transition, assessed using the Center for Epidemiological Studies Depression Scale for Children (CES-DC)
20-item scale with each item scored from 0 to 3 (overall range 0 to 60), with higher scores indicating higher depressive symptoms. Two time points compared in a before-after analysis.
Time frame: 4 weeks post-transition vs at transition
Sleep outcomes after vs before transition, assessed using the Child Sleep Habits Questionnaire (CSHQ) or Adolescent Sleep Habits Questionnaire (ASHQ)
33-item scale (2 items used in two subscales) with each item scored from 1 to 3, with higher scores indicating more sleep problems. Two time points compared in a before-after analysis.
Time frame: 4 weeks post-transition vs at transition
Health-related quality of life after vs before transition, assessed using the KINDL questionnaire
24-item scale with each item scored from 1 to five, with higher scores indicating higher health-related quality of life
Time frame: 4 weeks post-transition vs at transition
Proportion of participants with drug resistance among participants with viraemia while taking dolutegravir
Classified Stanford HIV drug resistance database (susceptible, potential low-level resistance, low-level resistance, intermediate resistance, high-level resistance) referring to each drug in the current ART regimen
Time frame: until 24 months after transition
Impact of drug resistance at time of transition on subsequent viral suppression
Assessment whether resistance at transition predicts subsequent routinely assessed viral load outcomes
Time frame: until 24 months after transition
Plan to share: Yes — De-identified data will be shared in a data repository upon publication of results.
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Sep 2023, 14 months.
Of 127 non-industry observational studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's 14 months is below that.
Counting every sponsor, half of 137 studies reached it within 18 months; a quarter within 4 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Swiss Tropical & Public Health Institute