HIV InfectionsNCT05312918
Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites in 3 countries.
Trial summary
Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 487 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Sep 2022to 25 Nov 2025
- 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
- Adult, Older adult
Study population: HIV-1 infected individuals who are transitioning from an NNRTI-based first-line to a Dolutegravir-based first-line treatment.
Who may be able to join
- Aged 18 years or over.
- Infected with HIV-1.
- On an NNRTI-based first-line for at least 6 months.
- Initiating a new 1st line ART based on DTG according to national recommendations.
- Agree to participate in the study and provide free, written and informed consent.
Who cannot join
- Infection with HIV-2 or HIV1+2.
- Ongoing participation in another virological study on HIV infection
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Togo1 site
Biolim/Fss/Ul
Lomé
About this study
Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy.
Secondary objectives
Read more
- Determine the level of virological suppression (HIV-1 RNA <200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line.
- Determine the level of virological suppression at the WHO threshold (HIV-1 RNA <1000 copies/ml).
- To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO.
- To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors.
- Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches.
Identify program factors associated with virological failure and/or the development of drug resistance.
Read the detailed description
Antiretroviral therapy (ART) has dramatically changed the pronostic of HIV/AIDS infection over the last 20 years, by reducing the mortality and morbibidity associted with the infection. This is mostly true in sub-Saharan African, the most affected region of the world. The UNAIDS 2019 report confirms this fact, and shows a significant reduction in the number of deaths related to HIV infection as access to antiretrovirals (ARV) increases. However, in the absence of cure by current treatments, the management and treatment of the infection should still be considered for life. This makes this management complex and challenging. Indeed, the risk of failure to treatment is real, this risk is accompanied by that of developing resistance to treatment, which should lead to a change in treatment. The limited number of molecules therefore requires the development of strategies that must be effective in maintaining virological suppression for as long as possible and should also limit the emergence and circulation of resistant viruses. To address these priorities, the World Health Organization (WHO) recommends since 2016, the introduction of a first-line ART more efficient and more robust, combining molecules with a high genetic barrier to resistance. In its latest 2019 recommendations for resource-limited countries, WHO recommends a first-line ART comprising two nucleoside reverse transcriptase inhibitors (NRTIs) and one integrase inhibitor (INI), preferably tenofovir (TDF)+Lamivudine (3TC )/emtricitabine (FTC)+dolutegravir (DTG). This new strategy is expected in the context of sub-Saharan Africa, where the increase of pre-treatment and acquired HIV drug resistance has been worrying for several years, but raises a certain number of uncertainties. Indeed, available and published data on the effectiveness of DTG are mainly from studies conducted in Northern countries, very few clinical trials have evaluated or are underway to evaluate the strategy in Southern countries and virtually no evaluation of the effectiveness of this approach in the context of real life in the South has been conducted to date. In addition, few or no recommendations have been made to accompany this transition to a new DTG-based first-line in the South. This is of greater concern for patients who are currently under non-NRTI-based first-line , and who will be switched to a new DTG-based first-line. This population will certainly include very variable virological profiles, ranging from patients in virological suppression, to patients who are not virologically suppressed, with potential accumulation of resistance mutations. In the absence of clear and funded recommendations for the organization of these transitions, the risk of this transition producing results below expectations is real and significant. In addition, the reality of the management of HIV infection in the South regularly faces significant challenges associated with limited financial and human resources. This often makes it difficult to apply decisions made even at the national level. For illustration, despite the unanimity around the use of viral load for monitoring people on ART, access to and the availability of this test in daily practice remains challenging in many countries. It is therefore essential to evaluate the virological response in people who will be switched from the current first-line, to the new first-line, in real life conditions, in the South. This study, developed and considered as a priority by the AC43 working group "Medical Virology" of the ANRS, aims to evaluate this new strategy in real life context in three countries of sub-Saharan Africa, Côte d'Ivoire, Mali and Togo. The main objective is to assess the virological efficacy of the DTG-based first-line in real life conditions, for patients initially receiving an NNRTI-based first-line, followed-up in the national programs and determine the impact of baseline NRTI-drug resistance on the success of the new strategy. All these three countries have adopted the new WHO recommendations and the deployment of the DTG-based first-line is being initiated. It is therefore essential that this research be conducted along side with this ongoing transition, so that the results will help developping adequate recommendations that will allow programs in the South to better organise the transition, to improve the therapeutic and virological monitoring of patients, to prevent early failures, and the emergence and rapid circulation of drug resistance.
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Dolutegravir, HIV drug resistance, Real Life
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion virological success
Proportion of patients with virological success at Week 48 (Month 12), defined by a VL <200 copies/ml.
Measured: 48 weeks
Secondary outcomes (31)
Virological suppression at W24 (VL< 200 copies/ml)
Proportion of patients with virological suppression at W24 (VL< 200 copies/ml).
Measured: 24 weeks
Virological suppression at W96 (VL< 200 copies/ml)
Proportion of patients with virological suppression at W96 (VL< 200 copies/ml).
Measured: 96 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W24 and the control viral load at W36 if the first point of viral load was >200 copies/ml.
Measured: 36 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >200 copies/ml.
Measured: 60 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >200 copies/ml.
Measured: 108 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Proportion of patients with virological suppression at the WHO threshold at W24 (< 1000 copies/ml).
Measured: 24 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Proportion of patients with virological suppression at the WHO threshold at W48 (< 1000 copies/ml).
Measured: 48 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Proportion of patients with virological suppression at the WHO threshold at W96 (< 1000 copies/ml).
Measured: 96 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >1000 copies/ml.
Measured: 36 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >1000 copies/ml.
Measured: 60 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >1000 copies/ml.
Measured: 108 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Proportion of patients with virological suppression at the optimal threshold at W24 (<50 copies/ml)
Measured: 24 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Proportion of patients with virological suppression at the optimal threshold at W48 (<50 copies/ml)
Measured: 48 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Proportion of patients with virological suppression at the optimal threshold at W96 (<50 copies/ml)
Measured: 96 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >50 copies/ml.
Measured: 36 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >50 copies/ml.
Measured: 60 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >50 copies/ml.
Measured: 108 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W24, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
Measured: 24 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W48, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
Measured: 48 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W96, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
Measured: 96 weeks
Frequency of drug resistance
Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 24 weeks
Profiles of resistance mutations
Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 24 weeks
Frequency of drug resistance
Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 48 weeks
Profiles of resistance mutations
Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 48 weeks
Frequency of drug resistance
Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 96 weeks
Profiles of resistance mutations
Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
Measured: 96 weeks
GSS (Genotypic susceptibility score)
Proportion of patients with a GSS ≤1 at W24
Measured: 24 weeks
GSS (Genotypic susceptibility score)
Proportion of patients with a GSS ≤1 at W48
Measured: 48 weeks
GSS (Genotypic susceptibility score)
Proportion of patients with a GSS ≤1 at W96.
Measured: 96 weeks
Frequency of pre-transition resistance mutations to NRTIs
Frequency of pre-transition resistance mutations to NRTIs
Measured: At baseline, before DTG initiation
Proportion of HIV minority variants
Proportion of minority variants (5% threshold) in patients with resistance mutations to NRTIs and/or DTG in the event of virological failure.
Measured: Up to 108 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start9 Sep 2022
- Primary completion9 Sep 2023
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- CIRBA, Abidjan, Ivory Coast, SEREFO, Bamako, Mali, BIOLIM/FSS/UL, Lomé, Togo
- Responsible party
- Sponsor
- Investigators
- Avelin AGHOKENG, Study director, IRD 224 - CNRS 5290 - UM1-UM2Anoumou Claver DAGNRA, Study director, BIOLIM - FSS - UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312918
- Sponsor's protocol ID
- ANRS 12427 DoReaL
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)
- ClinicalTrials.gov ID
- NCT05312918
- Acronym / sponsor ID
- ANRS 12427 DoReaL
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Dolutegravir, HIV drug resistance, Real Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- CIRBA, Abidjan, Ivory Coast, SEREFO, Bamako, Mali, BIOLIM/FSS/UL, Lomé, Togo
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 6 Apr 2022 (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.
Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy.
Secondary objectives
- Determine the level of virological suppression (HIV-1 RNA <200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line.
- Determine the level of virological suppression at the WHO threshold (HIV-1 RNA <1000 copies/ml).
- To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO.
- To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors.
- Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches.
Identify program factors associated with virological failure and/or the development of drug resistance.
Detailed description
Antiretroviral therapy (ART) has dramatically changed the pronostic of HIV/AIDS infection over the last 20 years, by reducing the mortality and morbibidity associted with the infection. This is mostly true in sub-Saharan African, the most affected region of the world. The UNAIDS 2019 report confirms this fact, and shows a significant reduction in the number of deaths related to HIV infection as access to antiretrovirals (ARV) increases. However, in the absence of cure by current treatments, the management and treatment of the infection should still be considered for life. This makes this management complex and challenging. Indeed, the risk of failure to treatment is real, this risk is accompanied by that of developing resistance to treatment, which should lead to a change in treatment. The limited number of molecules therefore requires the development of strategies that must be effective in maintaining virological suppression for as long as possible and should also limit the emergence and circulation of resistant viruses. To address these priorities, the World Health Organization (WHO) recommends since 2016, the introduction of a first-line ART more efficient and more robust, combining molecules with a high genetic barrier to resistance. In its latest 2019 recommendations for resource-limited countries, WHO recommends a first-line ART comprising two nucleoside reverse transcriptase inhibitors (NRTIs) and one integrase inhibitor (INI), preferably tenofovir (TDF)+Lamivudine (3TC )/emtricitabine (FTC)+dolutegravir (DTG). This new strategy is expected in the context of sub-Saharan Africa, where the increase of pre-treatment and acquired HIV drug resistance has been worrying for several years, but raises a certain number of uncertainties. Indeed, available and published data on the effectiveness of DTG are mainly from studies conducted in Northern countries, very few clinical trials have evaluated or are underway to evaluate the strategy in Southern countries and virtually no evaluation of the effectiveness of this approach in the context of real life in the South has been conducted to date. In addition, few or no recommendations have been made to accompany this transition to a new DTG-based first-line in the South. This is of greater concern for patients who are currently under non-NRTI-based first-line , and who will be switched to a new DTG-based first-line. This population will certainly include very variable virological profiles, ranging from patients in virological suppression, to patients who are not virologically suppressed, with potential accumulation of resistance mutations. In the absence of clear and funded recommendations for the organization of these transitions, the risk of this transition producing results below expectations is real and significant. In addition, the reality of the management of HIV infection in the South regularly faces significant challenges associated with limited financial and human resources. This often makes it difficult to apply decisions made even at the national level. For illustration, despite the unanimity around the use of viral load for monitoring people on ART, access to and the availability of this test in daily practice remains challenging in many countries. It is therefore essential to evaluate the virological response in people who will be switched from the current first-line, to the new first-line, in real life conditions, in the South. This study, developed and considered as a priority by the AC43 working group "Medical Virology" of the ANRS, aims to evaluate this new strategy in real life context in three countries of sub-Saharan Africa, Côte d'Ivoire, Mali and Togo. The main objective is to assess the virological efficacy of the DTG-based first-line in real life conditions, for patients initially receiving an NNRTI-based first-line, followed-up in the national programs and determine the impact of baseline NRTI-drug resistance on the success of the new strategy. All these three countries have adopted the new WHO recommendations and the deployment of the DTG-based first-line is being initiated. It is therefore essential that this research be conducted along side with this ongoing transition, so that the results will help developping adequate recommendations that will allow programs in the South to better organise the transition, to improve the therapeutic and virological monitoring of patients, to prevent early failures, and the emergence and rapid circulation of drug resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected individuals who are transitioning from an NNRTI-based first-line to a Dolutegravir-based first-line treatment.
Key inclusion criteria (5 listed)
- Aged 18 years or over.
- Infected with HIV-1.
- On an NNRTI-based first-line for at least 6 months.
- Initiating a new 1st line ART based on DTG according to national recommendations.
- Agree to participate in the study and provide free, written and informed consent.
Key exclusion criteria (2 listed)
- Infection with HIV-2 or HIV1+2.
- Ongoing participation in another virological study on HIV infection
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
Proportion virological success
Time frame: 48 weeks
Proportion of patients with virological success at Week 48 (Month 12), defined by a VL <200 copies/ml.
31 secondary outcomes
Virological suppression at W24 (VL< 200 copies/ml)
Time frame: 24 weeks
Virological suppression at W96 (VL< 200 copies/ml)
Time frame: 96 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time frame: 36 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time frame: 60 weeks
Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time frame: 108 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Time frame: 24 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Time frame: 48 weeks
Virological suppression at the WHO threshold (< 1000 copies/ml).
Time frame: 96 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time frame: 36 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time frame: 60 weeks
Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time frame: 108 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Time frame: 24 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Time frame: 48 weeks
Virological suppression at the optimal threshold (<50 copies/ml)
Time frame: 96 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time frame: 36 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time frame: 60 weeks
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time frame: 108 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time frame: 24 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time frame: 48 weeks
Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time frame: 96 weeks
Frequency of drug resistance
Time frame: 24 weeks
Profiles of resistance mutations
Time frame: 24 weeks
Frequency of drug resistance
Time frame: 48 weeks
Profiles of resistance mutations
Time frame: 48 weeks
Frequency of drug resistance
Time frame: 96 weeks
Profiles of resistance mutations
Time frame: 96 weeks
GSS (Genotypic susceptibility score)
Time frame: 24 weeks
GSS (Genotypic susceptibility score)
Time frame: 48 weeks
GSS (Genotypic susceptibility score)
Time frame: 96 weeks
Frequency of pre-transition resistance mutations to NRTIs
Time frame: At baseline, before DTG initiation
Proportion of HIV minority variants
Time frame: Up to 108 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 16 Oct 2026.
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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.
Avelin AGHOKENG study director
IRD 224 - CNRS 5290 - UM1-UM2
Anoumou Claver DAGNRA study director
BIOLIM - FSS - UL
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites in 3 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 5 inclusion and 2 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Côte d’Ivoire, Mali, Togo. 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?
Proportion virological success (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.