HIV-1-infectionGIVE MOVENCT04233242
Genotype-Informed Versus Empiric Management of VirEmia
A study testing Clinical management informed by HIV-1 genotypic resistance testing in people with HIV-1-infection, run by Swiss Tropical & Public Health Institute at 10 sites in 2 countries.
Trial summary
HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. Read more about this study
- Who is it for?
- Ages 6 months to 19 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Clinical management informed by HIV-1 genotypic resistance testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 3 Mar 2020to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- In care in a study site
- Age ≥6 months and <19 years
- Latest HIV viral load result ≥400 c/mL
- On an unchanged ART regimen for ≥6 months
- Phlebotomy for latest viral load test <4 months before screening
- Consent given
Who cannot join
- Indication for treatment switch according to WHO guidelines at screening
- 1st enhanced adherence counselling (EAC) session initiated >2 weeks prior to screening
- Intention to transfer out of the study site (and not into a different study site) within 3 months after randomisation
- Already enrolled in another study if judged as non-compatible by the (Local) Principal Investigator
- Pregnant or breastfeeding at screening (no exclusion based on pregnancy or breastfeeding after enrolment)
- Acute illness requiring hospitalisation at screening (no exclusion based on hospitalisation after enrolment)
- Received a resistance test in the last 12 months
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Lesotho6 sites
Baylor Clinic Butha-Buthe
Butha-Buthe
Baylor Clinic Leribe
Hlotse, Leribe District
Baylor Clinic Maseru
Maseru
Baylor Clinic Mohale's Hoek
Mohale's Hoek
Baylor Clinic Mokhotlong
Mokhotlong
Seboche Mission Hospital
Seboche, Butha-Buthe
Tanzania4 sites
Mbagala Rangi Tatu Hospital
Dar es Salaam
Temeke Regional Referral Hospital
Dar es Salaam
Upendano Dispensary
Dar es Salaam
One-Stop Clinic and Chronic Diseases Clinic (CDCI) at St Francis Referral Hospital
Ifakara, Morogoro
About this study
Official title: Genotype-Informed Versus Empiric Management of VirEmia (GIVE MOVE) in HIV-Infected Children and Adolescents on Antiretroviral Therapy: An Open-Label Randomised Clinical Trial
HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to determine which drug combinations are likely to be effective, this diagnostic tool is relatively costly and labour-intensive and is not routinely available in most resource-limited settings.
GIVE MOVE is a multi-country (Lesotho, Tanzania) randomised clinical trial assessing if rapid GRT after detecting an unsuppressed viral load improves the clinical management and thus health outcomes for children and adolescents living with HIV. Children and adolescents with an unsuppressed viral load despite ART are enrolled and randomly allocated to a control or an intervention arm (50% of participants in each arm). The control arm receives care according to the current standard of care, consisting of three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test. Onward treatment is informed by the outcome of this viral load test alongside empirical guidelines and clinical judgement. The intervention arm receives GRT and GRT-informed onward therapy. Participants in the intervention arm also receive three sessions of enhanced adherence counselling, which is informed by GRT results (i.e., if no drug resistance is detected, there is a high chance of suboptimal adherence to ART and this can be directly addressed).
This trial will assess if the rapid provision of GRT improves participants' health outcomes at 9 months after enrolment. A nested study will assess the cost and cost-effectiveness of GRT. Thus, this trial will provide evidence on whether the provision of GRT for children and adolescents with HIV should be prioritised in resource-limited settings.
Read the detailed description
Background and rationale:
Children and adolescents living with HIV and receiving antiretroviral therapy (ART) suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to select an optimal ART regimen, this diagnostic tool is not routinely available in many resource-limited settings.
Objective:
The GIVE MOVE trial assesses if rapid GRT after detection of an unsuppressed viral load in children and adolescents on ART improves health outcomes when compared to the current standard of care. Furthermore, a nested study will assess the cost-effectiveness of this intervention. Combined, these results will provide evidence on whether GRT should be prioritised for children and adolescents with HIV.
Study design:
GIVE MOVE is a multi-centre (several centres in 2 countries, Lesotho and Tanzania), parallel-group (1:1 allocation), open-label randomised clinical trial. Children and adolescents living with HIV with a viral load ≥400 c/mL are enrolled.
The control group is managed as per the current standard of care that follows the World Health Organization guidelines, i.e. three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test and viral load-informed onward treatment.
In the intervention arm, participants receive GRT, a GRT-informed treatment recommendation by a GRT Expert Committee, and GRT-informed onward therapy, selecting the best locally available drugs according to the drug resistance profile.
The GIVE MOVE trial will compare clinical outcomes (mortality, morbidity, viral suppression; see the Primary Outcome section for the composite primary endpoint) at nine months. Assuming that 20% vs 35% reach the primary endpoint in the intervention vs control arm, and at a significance level of 5%, 276 participants (138 per arm) are required to reach 80% power.
In addition to clinical outcomes, the trial intends to assess the cost and cost-effectiveness of the intervention. The GIVE MOVE trial aims at informing future clinical guidelines on the management of paediatric HIV.
- Conditions
- HIV-1-infection
- Being tested
- Clinical management informed by HIV-1 genotypic resistance testing
- Keywords
- HIV-1, acquired immunodeficiency syndrome, drug resistance, treatment failure, child, adolescent, Lesotho, Tanzania
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical management informed by HIV-1 genotypic resistance testingOther
The study intervention will consist of the following components:
- Genotypic resistance testing (GRT);
- Review of GRT results by an expert committee providing a treatment recommendation;
- GRT-based decision on further therapy (switch or maintain current ART regimen; choice of regimen); and
- GRT-informed adherence support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The viral load ≥400 c/mL before enrolment triggers genotypic resistance testing (GRT), followed by GRT-informed patient management and counselling. Onward treatment is informed by the resistance profile determined through GRT, with a GRT Expert Committee issuing a treatment recommendation. Receives: Other: Clinical management informed by HIV-1 genotypic resistance testing |
| Control | No intervention | Standard of care according to national guidelines and recommendations of the World Health Organization: The viral load ≥400 c/mL before enrolment is followed by 3 sessions of enhanced adherence counselling and a follow-up viral load test. Onward treatment is informed by viral load testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint
The composite primary endpoint is the occurrence of any one or more of the events i) death due to any cause during the follow-up period (36 weeks), ii) HIV- or ART-related hospital admission of ≥24 hours duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee blinded to the study arm) during the follow-up period (36 weeks), iii) new clinical World Health Organization (WHO) stage IV event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis; judged by the endpoint committee blinded to the study arm) during the follow-up period (36 weeks), and iv) no documentation of a suppressed viral load (<50 c/mL) at 9 months follow-up (window: 32-44 weeks). The primary endpoint will be assessed as an event ratio of participants reaching one or more of the composite endpoints.
Measured: At 9 months follow-up visit (window: 32-44 weeks)
Secondary outcomes (7)
Proportion with death due to any cause
Proportion of participants confirmed dead during the follow-period among all participants enrolled.
Measured: Within 36 weeks after baseline
Proportion with HIV- or ART-related hospital admission of ≥24 hours duration
Proportion of participants with HIV- or ART-related hospital admission of ≥24 hours duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee) during the follow-up period among all participants enrolled.
Measured: Within 36 weeks after baseline
Proportion with new clinical WHO stage IV event(s) (with some exclusions)
Proportion of participants with new clinical WHO stage IV event(s) (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis; judged by the endpoint committee) during the follow-up period among all participants enrolled.
Measured: Within 36 weeks after baseline
Proportion without documentation of a suppressed viral load
Proportion of participants without documentation of viral load <50 c/mL at 9 months among all participants enrolled.
Measured: At 9 months follow-up visit (window: 32-44 weeks)
Proportion lost to follow-up
Proportion of participants with no documented clinic visit at 9 months among all participants enrolled.
Measured: At 9 months follow-up visit (window: 32-44 weeks)
Proportion with observed virologic failure
Proportion of participants with a viral load ≥50 c/mL among all participants with a viral load result at 9 months.
Measured: At 9 months follow-up visit (window: 32-44 weeks)
Composite endpoint
This composite endpoint is the proportion of participants among all participants enrolled experiencing one or more of the events i) death due to any cause within 24 weeks of the decision on onward treatment, ii) HIV- or ART-related hospital admission of ≥24 hours duration (possibly, probably or definitely related to HIV or ART) within 24 weeks of the decision on onward treatment, iii) new clinical WHO stage IV event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis) within 24 weeks of the decision on onward treatment, and iv) no documentation of a suppressed viral load (<50 c/mL) at 6 months (window: 20-28 weeks) after the decision on onward treatment. The decision on onward treatment is defined as the first visit after the follow-up viral load result or resistance test result becomes available in the control or intervention arm, respectively.
Measured: 6 months (window: 20-28 weeks) after the decision on onward treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start3 Mar 2020
- Primary completion15 Mar 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, open-label, parallel-group (1:1 allocation), superiority randomised clinical trial
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Basel, SolidarMed, Partnerships for Health, Seboche Mission Hospital, Ifakara Health Institute, Baylor College of Medicine Children's Foundation
- Responsible party
- Sponsor
- Investigators
- Niklaus D Labhardt, MD, MIH, Study chair, Swiss Tropical & Public Health InstituteJennifer A Brown, PhD, Principal investigator, Swiss Tropical & Public Health InstituteThomas Klimkait, PhD, Study director, University of BaselJosephine Muhairwe, MD, MPH, Study director, SolidarMed, Partnerships for HealthBuntshi P Kayembe, MD, Study director, Baylor College of Medicine Children's FoundationMosa M Hlasoa, MD, Study director, Baylor College of Medicine Children's FoundationIsaac Ringera, MPH, RN, Study director, SolidarMed, Partnerships for HealthMaja Weisser, MD, Study director, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233242
- Sponsor's protocol ID
- P001-20-1.4
- Other IDs
- REG-19-008, ID 229-2019, Req-2019-01275, 12-2020, NIMR/HQ/R.8a/Vol. IX/3222, TMDA0020/CTR/0003/03
- Acronym
- GIVE MOVE
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication of the trial results, a subset of the key pseudo-anonymised individual participant data collected during the study, along with a data dictionary, will be made available through the data repository Zenodo. The full dataset will be made available upon request to the Division of Clinical Epidemiology at the University Hospital Basel and after signing a data confidentiality agreement.
Publications
Brown JA, Ringera I, Luoga E, Cheleboi M, Kimera N, Muhairwe J, Kayembe BP, Molapo Hlasoa M, Kabundi L, Yav CWD, Mothobi B, Thahane L, Amstutz A, Bachmann N, Mollel GJ, Bresser M, Glass TR, Paris DH, Klimkait T, Weisser M, Labhardt ND. Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania. BMC Infect Dis. 2020 Oct 19;20(1):773. doi: 10.1186/s12879-020-05491-9.
PubMed 33076866Brown JA, Ringera IK, Luoga E, Bresser M, Mothobi B, Kabundi L, Ilunga M, Mokhele K, Isaac AB, Tsoaeli N, Mbaya T, Simba B, Mayogu K, Mabula E, Cheleboi M, Molatelle M, Kimera N, Mollel GJ, Sando D, Tschumi N, Amstutz A, Thahane L, Hlasoa MM, Kayembe BP, Muhairwe J, Klimkait T, Glass TR, Weisser M, Labhardt ND. Resistance-informed versus empirical management of viraemia in children and adolescents with HIV in Lesotho and Tanzania (GIVE MOVE trial): a multisite, open-label randomised controlled trial. Lancet Glob Health. 2024 Aug;12(8):e1312-e1322. doi: 10.1016/S2214-109X(24)00183-9.
PubMed 39030062Schonenberger CM, Haenggi K, Ringera IK, Luoga E, Bresser M, Mothobi B, Mokhele K, Sando D, Molatelle M, Thahane L, Mnzava D, Ndege R, Hlasoa MM, Kayembe BP, Muhairwe J, Glass TR, Klimkait T, Weisser M, Labhardt ND, Tschumi N, Brown JA. HIV drug resistance amongst children and adolescents with viraemia in Lesotho and Tanzania: a nested analysis in the GIVE MOVE trial. J Antimicrob Chemother. 2026 Mar 4;81(4):dkag070. doi: 10.1093/jac/dkag070.
PubMed 41793741
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype-Informed Versus Empiric Management of VirEmia (GIVE MOVE) in HIV-Infected Children and Adolescents on Antiretroviral Therapy: An Open-Label Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04233242
- Acronym / sponsor ID
- GIVE MOVE / P001-20-1.4
- Conditions
- HIV-1-infection
- Keywords
- HIV-1, acquired immunodeficiency syndrome, drug resistance, treatment failure, child, adolescent, Lesotho, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Basel, SolidarMed, Partnerships for Health, Seboche Mission Hospital, Ifakara Health Institute, Baylor College of Medicine Children's Foundation
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to determine which drug combinations are likely to be effective, this diagnostic tool is relatively costly and labour-intensive and is not routinely available in most resource-limited settings.
GIVE MOVE is a multi-country (Lesotho, Tanzania) randomised clinical trial assessing if rapid GRT after detecting an unsuppressed viral load improves the clinical management and thus health outcomes for children and adolescents living with HIV. Children and adolescents with an unsuppressed viral load despite ART are enrolled and randomly allocated to a control or an intervention arm (50% of participants in each arm). The control arm receives care according to the current standard of care, consisting of three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test. Onward treatment is informed by the outcome of this viral load test alongside empirical guidelines and clinical judgement. The intervention arm receives GRT and GRT-informed onward therapy. Participants in the intervention arm also receive three sessions of enhanced adherence counselling, which is informed by GRT results (i.e., if no drug resistance is detected, there is a high chance of suboptimal adherence to ART and this can be directly addressed).
This trial will assess if the rapid provision of GRT improves participants' health outcomes at 9 months after enrolment. A nested study will assess the cost and cost-effectiveness of GRT. Thus, this trial will provide evidence on whether the provision of GRT for children and adolescents with HIV should be prioritised in resource-limited settings.
Detailed description
Background and rationale:
Children and adolescents living with HIV and receiving antiretroviral therapy (ART) suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to select an optimal ART regimen, this diagnostic tool is not routinely available in many resource-limited settings.
Objective:
The GIVE MOVE trial assesses if rapid GRT after detection of an unsuppressed viral load in children and adolescents on ART improves health outcomes when compared to the current standard of care. Furthermore, a nested study will assess the cost-effectiveness of this intervention. Combined, these results will provide evidence on whether GRT should be prioritised for children and adolescents with HIV.
Study design:
GIVE MOVE is a multi-centre (several centres in 2 countries, Lesotho and Tanzania), parallel-group (1:1 allocation), open-label randomised clinical trial. Children and adolescents living with HIV with a viral load ≥400 c/mL are enrolled.
The control group is managed as per the current standard of care that follows the World Health Organization guidelines, i.e. three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test and viral load-informed onward treatment.
In the intervention arm, participants receive GRT, a GRT-informed treatment recommendation by a GRT Expert Committee, and GRT-informed onward therapy, selecting the best locally available drugs according to the drug resistance profile.
The GIVE MOVE trial will compare clinical outcomes (mortality, morbidity, viral suppression; see the Primary Outcome section for the composite primary endpoint) at nine months. Assuming that 20% vs 35% reach the primary endpoint in the intervention vs control arm, and at a significance level of 5%, 276 participants (138 per arm) are required to reach 80% power.
In addition to clinical outcomes, the trial intends to assess the cost and cost-effectiveness of the intervention. The GIVE MOVE trial aims at informing future clinical guidelines on the management of paediatric HIV.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre, open-label, parallel-group (1:1 allocation), superiority randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Clinical management informed by HIV-1 genotypic resistance testingThe viral load ≥400 c/mL before enrolment triggers genotypic resistance testing (GRT), followed by GRT-informed patient management and counselling. Onward treatment is informed by the resistance profile determined through GRT, with a GRT Expert Committee issuing a treatment recommendation. |
| Control | No intervention | –Standard of care according to national guidelines and recommendations of the World Health Organization: The viral load ≥400 c/mL before enrolment is followed by 3 sessions of enhanced adherence counselling and a follow-up viral load test. Onward treatment is informed by viral load testing. |
Who may qualify
- Ages
- 6 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- In care in a study site
- Age ≥6 months and <19 years
- Latest HIV viral load result ≥400 c/mL
- On an unchanged ART regimen for ≥6 months
- Phlebotomy for latest viral load test <4 months before screening
Key exclusion criteria (7 listed)
- Indication for treatment switch according to WHO guidelines at screening
- 1st enhanced adherence counselling (EAC) session initiated >2 weeks prior to screening
- Intention to transfer out of the study site (and not into a different study site) within 3 months after randomisation
- Already enrolled in another study if judged as non-compatible by the (Local) Principal Investigator
- Pregnant or breastfeeding at screening (no exclusion based on pregnancy or breastfeeding after enrolment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical management informed by HIV-1 genotypic resistance testingThe study intervention will consist of the following components: 1. Genotypic resistance testing (GRT); 2. Review of GRT results by an expert committee providing a treatment recommendation; 3. GRT-based decision on further therapy (switch or maintain current ART regimen; choice of regimen); and 4. GRT-informed adherence support. | Other | Intervention |
Primary outcome
Composite primary endpoint
Time frame: At 9 months follow-up visit (window: 32-44 weeks)
The composite primary endpoint is the occurrence of any one or more of the events i) death due to any cause during the follow-up period (36 weeks), ii) HIV- or ART-related hospital admission of ≥24 hours duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee blinded to the study arm) during the follow-up period (36 weeks), iii) new clinical World Health Organization (WHO) stage IV event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis; judged by the endpoint committee blinded to the study arm) during the follow-up period (36 weeks), and iv) no documentation of a suppressed viral load (<50 c/mL) at 9 months follow-up (window: 32-44 weeks). The primary endpoint will be assessed as an event ratio of participants reaching one or more of the composite endpoints.
7 secondary outcomes
Proportion with death due to any cause
Time frame: Within 36 weeks after baseline
Proportion with HIV- or ART-related hospital admission of ≥24 hours duration
Time frame: Within 36 weeks after baseline
Proportion with new clinical WHO stage IV event(s) (with some exclusions)
Time frame: Within 36 weeks after baseline
Proportion without documentation of a suppressed viral load
Time frame: At 9 months follow-up visit (window: 32-44 weeks)
Proportion lost to follow-up
Time frame: At 9 months follow-up visit (window: 32-44 weeks)
Proportion with observed virologic failure
Time frame: At 9 months follow-up visit (window: 32-44 weeks)
Composite endpoint
Time frame: 6 months (window: 20-28 weeks) after the decision on onward treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 33076866Brown JA, Ringera I, Luoga E, Cheleboi M, Kimera N, Muhairwe J, Kayembe BP, Molapo Hlasoa M, Kabundi L, Yav CWD, Mothobi B, Thahane L, Amstutz A, Bachmann N, Mollel GJ, Bresser M, Glass TR, Paris DH, Klimkait T, Weisser M, Labhardt ND. Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania. BMC Infect Dis. 2020 Oct 19;20(1):773. doi: 10.1186/s12879-020-05491-9.
- Results publication: PubMed 39030062Brown JA, Ringera IK, Luoga E, Bresser M, Mothobi B, Kabundi L, Ilunga M, Mokhele K, Isaac AB, Tsoaeli N, Mbaya T, Simba B, Mayogu K, Mabula E, Cheleboi M, Molatelle M, Kimera N, Mollel GJ, Sando D, Tschumi N, Amstutz A, Thahane L, Hlasoa MM, Kayembe BP, Muhairwe J, Klimkait T, Glass TR, Weisser M, Labhardt ND. Resistance-informed versus empirical management of viraemia in children and adolescents with HIV in Lesotho and Tanzania (GIVE MOVE trial): a multisite, open-label randomised controlled trial. Lancet Glob Health. 2024 Aug;12(8):e1312-e1322. doi: 10.1016/S2214-109X(24)00183-9.
- Derived from this study: PubMed 41793741Schonenberger CM, Haenggi K, Ringera IK, Luoga E, Bresser M, Mothobi B, Mokhele K, Sando D, Molatelle M, Thahane L, Mnzava D, Ndege R, Hlasoa MM, Kayembe BP, Muhairwe J, Glass TR, Klimkait T, Weisser M, Labhardt ND, Tschumi N, Brown JA. HIV drug resistance amongst children and adolescents with viraemia in Lesotho and Tanzania: a nested analysis in the GIVE MOVE trial. J Antimicrob Chemother. 2026 Mar 4;81(4):dkag070. doi: 10.1093/jac/dkag070.
- trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon publication of the trial results, a subset of the key pseudo-anonymised individual participant data collected during the study, along with a data dictionary, will be made available through the data repository Zenodo. The full dataset will be made available upon request to the Division of Clinical Epidemiology at the University Hospital Basel and after signing a data confidentiality agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklaus D Labhardt, MD, MIH study chair
Swiss Tropical & Public Health Institute
Jennifer A Brown, PhD principal investigator
Swiss Tropical & Public Health Institute
Thomas Klimkait, PhD study director
University of Basel
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical management informed by HIV-1 genotypic resistance testing in people with HIV-1-infection, run by Swiss Tropical & Public Health Institute at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Lesotho, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: At 9 months follow-up visit (window: 32-44 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.