TY - JOUR
T1 - Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE)
T2 - study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania
AU - Brown, Jennifer Anne
AU - Ringera, Isaac
AU - Luoga, Ezekiel
AU - Cheleboi, Molisana
AU - Kimera, Namvua
AU - Muhairwe, Josephine
AU - Kayembe, Buntshi Paulin
AU - Molapo Hlasoa, Mosa
AU - Kabundi, Lorraine
AU - Yav, Ching Wey David
AU - Mothobi, Buoang
AU - Thahane, Lineo
AU - Amstutz, Alain
AU - Bachmann, Nadine
AU - Mollel, Getrud Joseph
AU - Bresser, Moniek
AU - Glass, Tracy Renée
AU - Paris, Daniel Henry
AU - Klimkait, Thomas
AU - Weisser, Maja
AU - Labhardt, Niklaus Daniel
PY - 2020/10/19
Y1 - 2020/10/19
N2 - BACKGROUND: Globally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).METHODS: GIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.DISCUSSION: This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov ( NCT04233242 ; registered 18.01.2020). More information: www.givemove.org .
AB - BACKGROUND: Globally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).METHODS: GIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.DISCUSSION: This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov ( NCT04233242 ; registered 18.01.2020). More information: www.givemove.org .
KW - Adolescent
KW - Anti-HIV Agents/pharmacology
KW - Child
KW - Child, Preschool
KW - Cost-Benefit Analysis
KW - Counseling
KW - Drug Resistance, Viral
KW - Female
KW - Genotype
KW - HIV/drug effects
KW - HIV Infections/drug therapy
KW - Herpes Genitalis
KW - Humans
KW - Infant
KW - Lesotho
KW - Longitudinal Studies
KW - Male
KW - Tanzania
KW - Treatment Failure
KW - Viral Load
KW - Viremia/drug therapy
U2 - 10.1186/s12879-020-05491-9
DO - 10.1186/s12879-020-05491-9
M3 - Article (Academic Journal)
C2 - 33076866
SN - 1471-2334
VL - 20
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 773
ER -
