HivDTG-SWITCHNCT04612452
The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART
An observational study of Hiv and Drug Resistancy, run by University of Bern at 2 sites in 2 countries.
Trial summary
This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Drug Resistancy, Virologic Failure
- How many people
- 2,820 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Nov 2019to 22 Mar 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV.
Who may be able to join
- Patients
- On first-line ART for 6 months or longer
- Switching to any DTG-based treatment
Who cannot join
- No informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
Read the detailed description
Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (InSTI), is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line ART regimen. In countries where viral load monitoring is not routinely available many patients on first-line ART will be switched to a DTG-based regimen despite the detectable viral load, which could increase the risk of selection of resistance to DTG as the majority of patients with virologic failure on first-line EFV-based ART have NRTI mutations. The investigators hypothesize that the proportion of patients experiencing virologic failure 48 and 96 weeks after switching to a DTG-based regimen will be higher in patients who switched with virologic failure (VL>400 copies/mL) compared to patients who switched with suppressed viral replication (VL<400 copies/mL). This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. At the time of switching to DTG, a baseline study assessment will be done, and a blood sample will be taken. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
- Conditions
- Hiv, Drug Resistancy, Virologic Failure
- Keywords
- Hiv, Drug resistancy, Virologic failure, DTG-based regimen, Drug resistance mutations
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Lighthouse Trust in Lilongwe | Not described | |
| CIDRZ in Lusaka | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with VF at 48 weeks between patients with and without VF at baseline.
Measured: 48 weeks
Secondary outcomes (10)
The proportion of patients with VF at 96 weeks between patients with and without VF at baseline.
Measured: 96 weeks
The incidence of TLD drug resistances at 48 and 96 weeks in patients with and without VF at switch.
Measured: 48 and 96 weeks
The proportion of HIV-infected patients with VF at baseline.
Measured: Baseline
The proportion of patients with VF at 48 weeks and 96 weeks in patients with VF at baseline who have at least one or no fully active NRTI on resistance testing.
Measured: 48 and 96 weeks
Prevalence of neuropsychiatric symptoms at baseline, 48 weeks and 96 weeks.
Measured: 48 and 96 weeks
Prevalence of insomnia at baseline, 48 weeks and 96 weeks.
Measured: 48 and 96 weeks
Weight change from baseline to 48 and 96 weeks.
Measured: 48 and 96 weeks
Levels of adherence at baseline and after 48 and 96 weeks.
Measured: 48 and 96 weeks
The number of clinical visits whilst on a DTG-based regimen up to 48 and 96 weeks.
Measured: 48 and 96 weeks
The number of clinical visits up to baseline, 48 and 96 weeks.
Measured: 48 and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start5 Nov 2019
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu, Lighthouse Trust, Centre for Infectious Disease Research in Zambia
- Responsible party
- Sponsor
- Investigators
- Matthias Egger, Prof., Study director, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612452
- Sponsor's protocol ID
- DTG-SWITCH Study protocol
- Acronym
- DTG-SWITCH
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Skrivankova VW, Huwa J, Muula G, Chiwaya GD, Banda E, Buleya S, Chihota B, Chintedza J, Bolton C, Tweya H, Kalua T, Hossmann S, Kouyos R, Wandeler G, Egger M, Lessells RJ. Virologic Failure and Drug Resistance After Programmatic Switching to Dolutegravir-based First-line Antiretroviral Therapy in Malawi and Zambia. Clin Infect Dis. 2025 Feb 5;80(1):120-128. doi: 10.1093/cid/ciae261.
PubMed 38847281
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART
- ClinicalTrials.gov ID
- NCT04612452
- Acronym / sponsor ID
- DTG-SWITCH / DTG-SWITCH Study protocol
- Conditions
- Hiv, Drug Resistancy, Virologic Failure
- Keywords
- Hiv, Drug resistancy, Virologic failure, DTG-based regimen, Drug resistance mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,820 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of KwaZulu, Lighthouse Trust, Centre for Infectious Disease Research in Zambia
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 3 Nov 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.
This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
Detailed description
Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (InSTI), is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line ART regimen. In countries where viral load monitoring is not routinely available many patients on first-line ART will be switched to a DTG-based regimen despite the detectable viral load, which could increase the risk of selection of resistance to DTG as the majority of patients with virologic failure on first-line EFV-based ART have NRTI mutations. The investigators hypothesize that the proportion of patients experiencing virologic failure 48 and 96 weeks after switching to a DTG-based regimen will be higher in patients who switched with virologic failure (VL>400 copies/mL) compared to patients who switched with suppressed viral replication (VL<400 copies/mL). This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. At the time of switching to DTG, a baseline study assessment will be done, and a blood sample will be taken. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lighthouse Trust in Lilongwe | – | – |
| CIDRZ in Lusaka | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV.
Key inclusion criteria (3 listed)
- Patients
- On first-line ART for 6 months or longer
- Switching to any DTG-based treatment
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients with VF at 48 weeks between patients with and without VF at baseline.
Time frame: 48 weeks
10 secondary outcomes
The proportion of patients with VF at 96 weeks between patients with and without VF at baseline.
Time frame: 96 weeks
The incidence of TLD drug resistances at 48 and 96 weeks in patients with and without VF at switch.
Time frame: 48 and 96 weeks
The proportion of HIV-infected patients with VF at baseline.
Time frame: Baseline
The proportion of patients with VF at 48 weeks and 96 weeks in patients with VF at baseline who have at least one or no fully active NRTI on resistance testing.
Time frame: 48 and 96 weeks
Prevalence of neuropsychiatric symptoms at baseline, 48 weeks and 96 weeks.
Time frame: 48 and 96 weeks
Prevalence of insomnia at baseline, 48 weeks and 96 weeks.
Time frame: 48 and 96 weeks
Weight change from baseline to 48 and 96 weeks.
Time frame: 48 and 96 weeks
Levels of adherence at baseline and after 48 and 96 weeks.
Time frame: 48 and 96 weeks
The number of clinical visits whilst on a DTG-based regimen up to 48 and 96 weeks.
Time frame: 48 and 96 weeks
The number of clinical visits up to baseline, 48 and 96 weeks.
Time frame: 48 and 96 weeks
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 24 Mar 2023.
- Derived from this study: PubMed 38847281Skrivankova VW, Huwa J, Muula G, Chiwaya GD, Banda E, Buleya S, Chihota B, Chintedza J, Bolton C, Tweya H, Kalua T, Hossmann S, Kouyos R, Wandeler G, Egger M, Lessells RJ. Virologic Failure and Drug Resistance After Programmatic Switching to Dolutegravir-based First-line Antiretroviral Therapy in Malawi and Zambia. Clin Infect Dis. 2025 Feb 5;80(1):120-128. doi: 10.1093/cid/ciae261.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Egger, Prof. study director
University of Berne
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Drug Resistancy, run by University of Bern at 2 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 3 inclusion and 1 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Zambia. 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?
The proportion of patients with VF at 48 weeks between patients with and without VF at baseline. (time frame: 48 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 NCT04612452, which also lists 1 linked publication.
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 24 Mar 2023.