HIV/AIDSSESOTHONCT03088241
"Switch Either Near Suppression Or THOusand"
A study testing switch in people with HIV/AIDS, run by Niklaus Labhardt at 8 sites in Lesotho.
Trial summary
This trial addresses the question of the viral load (VL) threshold for switching from first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold at 1000 copies/mL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- switch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesLesotho
- Study dates
- 1 Aug 2017to 23 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- On NNRTI-based first-line ART with two consecutive unsuppressed VL equal/more 100 copies/mL, with the second VL between 100 and 999 copies/mL.
- Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the study-facilities
- Signed written informed consent. For children aged <16 years, a main caregiver, and for illiterate a literate witness, has to provide oral and written informed consent.
Who cannot join
- On ART less than 6 months
- On protease-inhibitor containing ART or any other second-line ART
- Bad adherence (self-reported at least 1 dose missing in the last 4 weeks, resp. 2 doses of a twice-daily-regimen)
- Clinical WHO stage 3 or 4 at enrolment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Lesotho8 sites
Butha-Buthe Hospital
Butha-Buthe, 400
Seboche Hospital
Butha-Buthe, 400
Muela Health Center
Butha-Buthe
St. Paul Health Center
Butha-Buthe
St. Peters Health Center
Butha-Buthe
Motebang Hospital, ART corner
Hlotse, Leribe District
Senkatana ART clinic
Maseru
Mokhotlong Hospital
Mokhotlong
About this study
Official title: Switch to Second-line Versus WHO-guided Standard of Care for Unsuppressed Patients on First-line ART With Viremia Below 1000 Copies/mL - a Multicenter, Parallel-group, Open-label, Randomized Clinical Study in Rural Lesotho
This trial addresses the question of the viral load (VL) threshold for switching from first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold at 1000 copies/mL. However, the optimal threshold for defining virological failure and the need to switch ART regimen has not been determined. In fact, people with VL levels of less than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance mutations (DRM) and subsequent virological failure. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications and patients may continue on a failing regimen for a long period. Our research consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed HIV-positive patients on first-line ART will lead to better outcomes.
Read the detailed description
Study background \& rational:
The Joint United Nations Programme on HIV/AIDS (UNAIDS) launched the 90-90-90 targets for 2020 based on the result of newly-acquired scientific evidence that - irrespective of CD4 count - early antiretroviral treatment (ART) for HIV-positive individuals is beneficial to them and prevents HIV transmission. UNAIDS expects that the 90-90-90 targets will lead to a reduction in the yearly global HIV incidence from 2 million currently to 500,000 by 2020.
A crucial step to achieve the third pillar of the UNAIDS 90-90-90 targets - 90% viral suppression among HIV-positive individuals on treatment - and thus ensure a successful treatment outcome is the monitoring and management of first-line ART failure.
Since 2013, the WHO recommends routine viral load (rVL) measurement as the preferred monitoring strategy in resource-limited settings and defines virological failure as confirmed VL 1000 copies/mL despite good adherence. Specifically, the guidelines recommend that in case of a VL ≥ 1000 copies/mL the patient should undergo enhanced adherence support and a second VL test 3 months later. A second VL ≥ 1000 copies/mL with confirmed good adherence would trigger the switch to a second-line regimen, whereas if the VL is < 1000 copies/mL the patient should continue unaltered first-line ART. However, the optimal threshold for defining virological failure and the need for switching ART regimen has not yet been determined. In fact, people with VL levels of less than 1000 copies/mL, but not fully suppressed (usually defined as 50-100 copies/mL), are at a increased risk for drug resistance mutations (DRM) and subsequent virological failure. A recently published study from our research consortium in Lesotho indicates similar findings, demonstrating a significant accumulation of drug resistance mutations in patients with VL levels of less than 1000 copies/mL.
The VL threshold of 1000 copies/mL recommended by the WHO and the Lesotho national guidelines for the switch to second-line ART is likely to miss a substantial number of patients on first-line ART with persisting virus replication below 1000 copies/mL with DRM. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications: after a VL below 1000 copies/mL the patient may not receive a follow-up VL for up to a year, and thus may continue on a failing regimen for a long period of time. In conclusion, such patients are at increased risk for DRM, accumulation of further resistance mutations, drug-resistant virus transmission, and subsequent virological failure.
Study hypothesis:
Our research consortium hypothesizes that in patients on first-line ART with two consecutive unsuppressed VL measurements equal/more than 100 copies/mL, where the second VL is between 100 and 999 copies/mL, switch to second-line ART (intervention group) will lead to a higher rate of viral resuppression (VL < 50 copies/mL) and is therefore superior compared to not switching to second-line ART according to WHO guidelines (control group, standard of care).
Study design:
Multicenter (2-12 centers), parallel-group (1:1 allocation), open-label, superiority, prospective randomized clinical study.
- Conditions
- HIV/AIDS
- Being tested
- switch
- Keywords
- randomized clinical trial, low level viremia, lesotho, resource-limited setting, ART first-line failure
- 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.
switchOther
switch to second-line ART
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | switch to second-line ART Receives: Other: switch |
| Control | No intervention | Standard of care: no switch to second-line ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral suppression
Proportion of virologically suppressed (VL < 50 copies/mL) participants 9 months after randomization.
Measured: 9 months after randomization
Secondary outcomes (14)
Proportion of participants with different VL thresholds (VL <100, <200, <400, <1000 copies/mL) at 9 months after randomization
Measured: 9 months after randomization
Adherence at 3, 6, 9 months, assessed by self-reported dose omission
Measured: 3, 6, 9 months after randomization
Change in values (versus values at baseline) of body-weight (kg) at 9 months
Measured: 9 months after randomization
Change in values (versus values at baseline) of haemoglobin (g/dL) at 9 months
Measured: 9 months after randomization
Change in values (versus values at baseline) of CD4 count (cells/mL) at 9 months
Measured: 9 months after randomization
Change in values (versus values at baseline) of lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l) at 9 months
Measured: 9 months after randomization
Change in values (versus values at baseline) of new clinical WHO 3 or 4 events (proportion) count at 9 months
Measured: 9 months after randomization
Change in values (versus values at baseline) of deaths (all-causes) (proportion) at 9 months
Measured: 9 months after randomization
Proportion of patients with adverse events and serious adverse events at 9 months after randomization
Measured: 9 months after randomization
Long-term follow-up endpoint: Proportion of patients that are alive, retained in care and virologically suppressed (VL < 50 copies/mL) at 24 months
Measured: 24 months after randomization
Proportion of virologically suppressed (VL < 50 copies/mL) participants by demographic groups (children vs pregnant women vs adults)
Measured: 9 months after randomization
Proportion of virologically suppressed (VL < 50 copies/mL) participants by different VL groups at enrolment (VL 100-599 vs 600-999 copies/mL copies/mL)
Measured: 9 months after randomization
Proportion of participants with viral resuppression (<50 copies/mL)
Measured: 6 months after randomization
Sustained virologic failure
Proportion of participants with unsuppressed VL >50 copies/mL at 6 and 9 months
Measured: 6 and 9 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Aug 2017
- Primary completion23 May 2020
- Study completion23 May 2020
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/AIDSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter (2-12 centers), parallel-group (1:1 allocation), open-label, superiority, prospective randomized clinical study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niklaus Labhardt
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, SolidarMed, Lucerne, Switzerland, SolidarMed, University of Basel, University Hospital, Basel, Switzerland, Butha-Buthe Hospital, Lesotho, Ministry of Health, Lesotho
- Responsible party
- Sponsor-investigator, Niklaus Labhardt, Swiss Tropical & Public Health Institute
- Investigators
- Niklaus Labhardt, MD MIH, Principal investigator, Swiss Tropical and Public Health Institute, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088241
- Sponsor's protocol ID
- P002-17-1.0
- Acronym
- SESOTHO
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD (baseline characteristics, outcomes, follow-up data) will eventually be shared after completion of the study upon request.
Publications
Amstutz A, Nsakala BL, Vanobberghen F, Muhairwe J, Glass TR, Achieng B, Sepeka M, Tlali K, Sao L, Thin K, Klimkait T, Battegay M, Labhardt ND. SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa. BMC Infect Dis. 2018 Feb 12;18(1):76. doi: 10.1186/s12879-018-2979-y.
PubMed 29433430Amstutz A, Nsakala BL, Vanobberghen F, Muhairwe J, Glass TR, Namane T, Mpholo T, Battegay M, Klimkait T, Labhardt ND. Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho. PLoS Med. 2020 Sep 16;17(9):e1003325. doi: 10.1371/journal.pmed.1003325. eCollection 2020 Sep.
PubMed 32936795Brown JA, Amstutz A, Nsakala BL, Seeburg U, Vanobberghen F, Muhairwe J, Klimkait T, Labhardt ND. Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial. J Antimicrob Chemother. 2021 Apr 13;76(5):1294-1298. doi: 10.1093/jac/dkab025.
PubMed 33599270
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Second-line Versus WHO-guided Standard of Care for Unsuppressed Patients on First-line ART With Viremia Below 1000 Copies/mL - a Multicenter, Parallel-group, Open-label, Randomized Clinical Study in Rural Lesotho
- ClinicalTrials.gov ID
- NCT03088241
- Acronym / sponsor ID
- SESOTHO / P002-17-1.0
- Conditions
- HIV/AIDS
- Keywords
- randomized clinical trial, low level viremia, lesotho, resource-limited setting, ART first-line failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Niklaus LabhardtUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, SolidarMed, Lucerne, Switzerland, SolidarMed, University of Basel, University Hospital, Basel, Switzerland, Butha-Buthe Hospital, Lesotho, Ministry of Health, Lesotho
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 23 May 2020 (actual)
- Study completion
- 23 May 2020 (actual)
- First posted
- 23 Mar 2017 (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.
This trial addresses the question of the viral load (VL) threshold for switching from first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold at 1000 copies/mL. However, the optimal threshold for defining virological failure and the need to switch ART regimen has not been determined. In fact, people with VL levels of less than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance mutations (DRM) and subsequent virological failure. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications and patients may continue on a failing regimen for a long period. Our research consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed HIV-positive patients on first-line ART will lead to better outcomes.
Detailed description
Study background \& rational:
The Joint United Nations Programme on HIV/AIDS (UNAIDS) launched the 90-90-90 targets for 2020 based on the result of newly-acquired scientific evidence that - irrespective of CD4 count - early antiretroviral treatment (ART) for HIV-positive individuals is beneficial to them and prevents HIV transmission. UNAIDS expects that the 90-90-90 targets will lead to a reduction in the yearly global HIV incidence from 2 million currently to 500,000 by 2020.
A crucial step to achieve the third pillar of the UNAIDS 90-90-90 targets - 90% viral suppression among HIV-positive individuals on treatment - and thus ensure a successful treatment outcome is the monitoring and management of first-line ART failure.
Since 2013, the WHO recommends routine viral load (rVL) measurement as the preferred monitoring strategy in resource-limited settings and defines virological failure as confirmed VL 1000 copies/mL despite good adherence. Specifically, the guidelines recommend that in case of a VL ≥ 1000 copies/mL the patient should undergo enhanced adherence support and a second VL test 3 months later. A second VL ≥ 1000 copies/mL with confirmed good adherence would trigger the switch to a second-line regimen, whereas if the VL is < 1000 copies/mL the patient should continue unaltered first-line ART. However, the optimal threshold for defining virological failure and the need for switching ART regimen has not yet been determined. In fact, people with VL levels of less than 1000 copies/mL, but not fully suppressed (usually defined as 50-100 copies/mL), are at a increased risk for drug resistance mutations (DRM) and subsequent virological failure. A recently published study from our research consortium in Lesotho indicates similar findings, demonstrating a significant accumulation of drug resistance mutations in patients with VL levels of less than 1000 copies/mL.
The VL threshold of 1000 copies/mL recommended by the WHO and the Lesotho national guidelines for the switch to second-line ART is likely to miss a substantial number of patients on first-line ART with persisting virus replication below 1000 copies/mL with DRM. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications: after a VL below 1000 copies/mL the patient may not receive a follow-up VL for up to a year, and thus may continue on a failing regimen for a long period of time. In conclusion, such patients are at increased risk for DRM, accumulation of further resistance mutations, drug-resistant virus transmission, and subsequent virological failure.
Study hypothesis:
Our research consortium hypothesizes that in patients on first-line ART with two consecutive unsuppressed VL measurements equal/more than 100 copies/mL, where the second VL is between 100 and 999 copies/mL, switch to second-line ART (intervention group) will lead to a higher rate of viral resuppression (VL < 50 copies/mL) and is therefore superior compared to not switching to second-line ART according to WHO guidelines (control group, standard of care).
Study design:
Multicenter (2-12 centers), parallel-group (1:1 allocation), open-label, superiority, prospective randomized clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter (2-12 centers), parallel-group (1:1 allocation), open-label, superiority, prospective randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: switchswitch to second-line ART |
| Control | No intervention | –Standard of care: no switch to second-line ART |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- On NNRTI-based first-line ART with two consecutive unsuppressed VL equal/more 100 copies/mL, with the second VL between 100 and 999 copies/mL.
- Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the study-facilities
- Signed written informed consent. For children aged <16 years, a main caregiver, and for illiterate a literate witness, has to provide oral and written informed consent.
Key exclusion criteria (4 listed)
- On ART less than 6 months
- On protease-inhibitor containing ART or any other second-line ART
- Bad adherence (self-reported at least 1 dose missing in the last 4 weeks, resp. 2 doses of a twice-daily-regimen)
- Clinical WHO stage 3 or 4 at 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 |
|---|---|---|
| switchswitch to second-line ART | Other | Intervention |
Primary outcome
viral suppression
Time frame: 9 months after randomization
Proportion of virologically suppressed (VL < 50 copies/mL) participants 9 months after randomization.
14 secondary outcomes
Proportion of participants with different VL thresholds (VL <100, <200, <400, <1000 copies/mL) at 9 months after randomization
Time frame: 9 months after randomization
Adherence at 3, 6, 9 months, assessed by self-reported dose omission
Time frame: 3, 6, 9 months after randomization
Change in values (versus values at baseline) of body-weight (kg) at 9 months
Time frame: 9 months after randomization
Change in values (versus values at baseline) of haemoglobin (g/dL) at 9 months
Time frame: 9 months after randomization
Change in values (versus values at baseline) of CD4 count (cells/mL) at 9 months
Time frame: 9 months after randomization
Change in values (versus values at baseline) of lipids (total cholesterol, LDL, HDL, triglycerides; mmol/l) at 9 months
Time frame: 9 months after randomization
Change in values (versus values at baseline) of new clinical WHO 3 or 4 events (proportion) count at 9 months
Time frame: 9 months after randomization
Change in values (versus values at baseline) of deaths (all-causes) (proportion) at 9 months
Time frame: 9 months after randomization
Proportion of patients with adverse events and serious adverse events at 9 months after randomization
Time frame: 9 months after randomization
Long-term follow-up endpoint: Proportion of patients that are alive, retained in care and virologically suppressed (VL < 50 copies/mL) at 24 months
Time frame: 24 months after randomization
Proportion of virologically suppressed (VL < 50 copies/mL) participants by demographic groups (children vs pregnant women vs adults)
Time frame: 9 months after randomization
Proportion of virologically suppressed (VL < 50 copies/mL) participants by different VL groups at enrolment (VL 100-599 vs 600-999 copies/mL copies/mL)
Time frame: 9 months after randomization
Proportion of participants with viral resuppression (<50 copies/mL)
Time frame: 6 months after randomization
Sustained virologic failure
Time frame: 6 and 9 months after randomization
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 22 Mar 2022.
- Background: PubMed 29433430Amstutz A, Nsakala BL, Vanobberghen F, Muhairwe J, Glass TR, Achieng B, Sepeka M, Tlali K, Sao L, Thin K, Klimkait T, Battegay M, Labhardt ND. SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa. BMC Infect Dis. 2018 Feb 12;18(1):76. doi: 10.1186/s12879-018-2979-y.
- Results publication: PubMed 32936795Amstutz A, Nsakala BL, Vanobberghen F, Muhairwe J, Glass TR, Namane T, Mpholo T, Battegay M, Klimkait T, Labhardt ND. Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho. PLoS Med. 2020 Sep 16;17(9):e1003325. doi: 10.1371/journal.pmed.1003325. eCollection 2020 Sep.
- Derived from this study: PubMed 33599270Brown JA, Amstutz A, Nsakala BL, Seeburg U, Vanobberghen F, Muhairwe J, Klimkait T, Labhardt ND. Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial. J Antimicrob Chemother. 2021 Apr 13;76(5):1294-1298. doi: 10.1093/jac/dkab025.
- Individual participant dataSharing planned: Undecided. IPD (baseline characteristics, outcomes, follow-up data) will eventually be shared after completion of the study upon request.
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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 Labhardt, MD MIH principal investigator
Swiss Tropical and Public Health Institute, Basel
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing switch in people with HIV/AIDS, run by Niklaus Labhardt at 8 sites in Lesotho.
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 3 inclusion and 4 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Lesotho. 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?
viral suppression (time frame: 9 months after randomization). 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 NCT03088241, 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 22 Mar 2022.