HIVARDOLNCT07618507
Resistance Profile to Antiretroviral Medications in Individuals Living With HIV Who Failed a First-Line Regimen With Tenofovir / Lamivudina and Dolutegravir in Brasil
A study testing TL+D antiretroviral in people with HIV and HIV -1 Infection, run by Federal University of São Paulo at 9 sites in Brazil.
Trial summary
The goal of this study is to understand the profile of individuals who demonstrate transmitted drug resistance to Dolutegravir (DTG) among PLHIV in Brazil in terms of the subtypes of virus and other individual characteristics after 24 weeks of treatment with a regimen of DTG, Tenofovir, and Lamivudine (TL+D). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV, HIV -1 Infection
- What is being tested?
- TL+D antiretroviral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 777 participants
- Where
- 9 sitesBrazil
- Study dates
- 13 Apr 2022to 8 Mar 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 ART therapy naive
Who cannot join
- Resistant to reverse transcriptase inhibitor drugs (NRTI)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
Centro Especializado em Doenças Infecciosas (CEDIN-DF)
Brasília, Federal District, 70351-580
Unidade de Infectologia William Rocha
Guarujá, São Paulo, 11471-000
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, Amazonas, 69040-000
LADI - Laboratório de Apoio Diagnóstico em Infectologia (Hospital Universitário Miguel Riet Corrêa Jr)
Porto Alegre, Rio Grande do Sul, 90040-000
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Centro Estadual Especializado em Diagnóstico, Assistência e Pesquisa (CEDAP)
Salvador, Estado de Bahia, 40100-160
Retrovirology Laboratory - UNIFESP
São Paulo, São Paulo, 04039-032
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070
Serviço Especializado em IST/HIV/AIDS Viamão
Viamão, Rio Grande do Sul, 94480-560
About this study
The goal of this study is to understand the profile of individuals who demonstrate transmitted drug resistance to Dolutegravir (DTG) among PLHIV in Brazil in terms of the subtypes of virus and other individual characteristics after 24 weeks of treatment with a regimen of DTG, Tenofovir, and Lamivudine (TL+D). The study also seeks to determine what alterations occur in the 3'-PPT region of the HIV virus in patients with failing the TL+D regimen.
The test group will be compared to a control group of individuals randomly selected whose viral control remains below detection limit (50 copies/mL) for 24 weeks after the initiation of treatment. The study uses clinics in cities in each of the five regions of Brazil: South region (Porto Alegre, Viamão), Southeast region (São Paulo, Santos, Guarujá), Northeast region (Salvador), Center West region (Brasília), and the North region (Manaus). Porto Alegre and Viamão are of interest because of the strong presence of subtype C in the South region. Salvador is a focus for subtype F of HIV. Finally, in Santos there is a strong presence of recombinant forms of subtypes F and B. These non-B subtypes are important to the study as they are typical of other medium and low income countries.
The plan for the study includes 200 cases who will receive the TL+D medication for 24 weeks (50 in each region) and 400 controls again spread among the regions on a 1 (case): 2(control ratio.
Read the detailed description
In November 2018, 170,000 individuals were receiving Dolutegravir through the public health system. It is a public health priority to evaluate the risk of virological failure and the subsequent development of resistance to integrase inhibitors in our setting. It has recently been shown that, in addition to resistance mutations in the integrase region of the pol gene, mutations in the 3'-PPT region (nef gene) also emerge and contribute to decreased susceptibility to Dolutegravir. The objectives of this work are to investigate the influence of transmitted antiretroviral resistance, the profile of HIV subtypes, and immunological and virological characteristics among individuals who failed first-line treatment with Tenofovir/Lamivudine and Dolutegravir (TL+D) after 24 weeks of treatment in Brazil. The investigators also seek to determine the genotypic resistance profile among individuals who failed the first-line TL+D regimen after 24 weeks of treatment in Brazil. To determine what alterations in the 3'-PPT are observed in viruses from patients failing TL+D and to assess if this new resistance pathway contributes to acquired resistance to the drug in clinical practice.
This is a nested case-control prospective study comparing in a 2:1 ratio the baseline HIV-1 genotypic profile of individuals with virological failure on the TL+D regimen after 24 weeks of treatment (cases) to randomly selected individuals with viral control with viral load below the detection limits of 50 copies/mL, 24 weeks after treatment initiation (controls).
HYPOTHESIS: The central hypothesis is that transmitted drug resistance (TDR) may be associated with and contribute to virological failure with dolutegravir (DTG) in clinical practice. To test this central hypothesis, we will identify DTG-containing regimens with failure in people living with HIV in Brazil, a model country for large-scale DTG implementation, where multiple HIV subtypes cocirculate.
PRIMARY RESEARCH OBJECTIVE:
- Investigate the influence of transmitted drug resistance, the profile of HIV subtypes, and immunological and virological characteristics among individuals who failed the first-line TL+D regimen after 24 weeks of treatment in Brazil.
- Determine the genotypic resistance profile among individuals who failed first-line TL+D after 24 weeks of treatment in Brazil.
- Determine what alterations in the 3'-PPT are observed in viruses from patients failing TL+D and assess if this new resistance pathway contributes to acquired drug resistance in clinical practice.
RISK AND BENEFIT ASSESSMENT:
RISKS: The risks associated with this study include discomfort at the needle puncture site for blood draws or the possible appearance of a bruise. Discomfort or occasional bruising occur with the same frequency as any blood draw for exams that a patient is already accustomed to.
BENEFITS: Patients will receive no direct benefit from participation in this study. The resistance tests performed may eventually help in selecting more effective antiretroviral drugs if treatment is not fully effective in controlling the HIV in the body. There will be no financial costs or compensation for participation in this study.
- Conditions
- HIV, HIV -1 Infection
- Being tested
- TL+D antiretroviral
- Keywords
- DTG, TDR, transmitted drug resistance, subtype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL+D antiretroviralDrug
Patients will receive the Tenofovir/Lamiduvine NRTI drugs along with the Dolutegravir for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TL+D | Active comparator | TL+D regimen of antiretroviral drugs for 24 weeks Receives: Drug: TL+D antiretroviral |
| Control | No intervention | Individuals chosen who have not failed an HIV drug regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of TDR
Comparative analysis of transmitted drug resistance between arms of the study
Measured: 3 months
Secondary outcomes (4)
Distribution of subtypes among regions
The distribution of subtypes in the five regions of Brazil in light of existence or not of TDR
Measured: 4 months
Sequence of 3'-PPT region of NEF
Comparison of the sequence of the 3'-PPT region of the NEF gene related to the existence of TDR, subtype and region
Measured: 6 months
Viral Load
Descriptive analysis of viral load for cases and controls at baseline, week 12 and week 24, including comparison related to presence of TDR and subtypes
Measured: 6 months
CD4+ Levels
Analysis of CD4+ levels at baseline, week 12 and week 24 in relation to presence of TDR, subtype and region
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start13 Apr 2022
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Ricardo Sobhie Diaz, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618507
- Sponsor's protocol ID
- SPARC-10
- Acronym
- ARDOL
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sponsors plan to divulge all the anonymized data through a publicly available repository at a site to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Profile to Antiretroviral Medications in Individuals Living With HIV Who Failed a First-Line Regimen With Tenofovir / Lamivudina and Dolutegravir in Brasil
- ClinicalTrials.gov ID
- NCT07618507
- Acronym / sponsor ID
- ARDOL / SPARC-10
- Conditions
- HIV, HIV -1 Infection
- Keywords
- DTG, TDR, transmitted drug resistance, subtype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 1 Jun 2026 (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.
The goal of this study is to understand the profile of individuals who demonstrate transmitted drug resistance to Dolutegravir (DTG) among PLHIV in Brazil in terms of the subtypes of virus and other individual characteristics after 24 weeks of treatment with a regimen of DTG, Tenofovir, and Lamivudine (TL+D). The study also seeks to determine what alterations occur in the 3'-PPT region of the HIV virus in patients with failing the TL+D regimen.
The test group will be compared to a control group of individuals randomly selected whose viral control remains below detection limit (50 copies/mL) for 24 weeks after the initiation of treatment. The study uses clinics in cities in each of the five regions of Brazil: South region (Porto Alegre, Viamão), Southeast region (São Paulo, Santos, Guarujá), Northeast region (Salvador), Center West region (Brasília), and the North region (Manaus). Porto Alegre and Viamão are of interest because of the strong presence of subtype C in the South region. Salvador is a focus for subtype F of HIV. Finally, in Santos there is a strong presence of recombinant forms of subtypes F and B. These non-B subtypes are important to the study as they are typical of other medium and low income countries.
The plan for the study includes 200 cases who will receive the TL+D medication for 24 weeks (50 in each region) and 400 controls again spread among the regions on a 1 (case): 2(control ratio.
Detailed description
In November 2018, 170,000 individuals were receiving Dolutegravir through the public health system. It is a public health priority to evaluate the risk of virological failure and the subsequent development of resistance to integrase inhibitors in our setting. It has recently been shown that, in addition to resistance mutations in the integrase region of the pol gene, mutations in the 3'-PPT region (nef gene) also emerge and contribute to decreased susceptibility to Dolutegravir. The objectives of this work are to investigate the influence of transmitted antiretroviral resistance, the profile of HIV subtypes, and immunological and virological characteristics among individuals who failed first-line treatment with Tenofovir/Lamivudine and Dolutegravir (TL+D) after 24 weeks of treatment in Brazil. The investigators also seek to determine the genotypic resistance profile among individuals who failed the first-line TL+D regimen after 24 weeks of treatment in Brazil. To determine what alterations in the 3'-PPT are observed in viruses from patients failing TL+D and to assess if this new resistance pathway contributes to acquired resistance to the drug in clinical practice.
This is a nested case-control prospective study comparing in a 2:1 ratio the baseline HIV-1 genotypic profile of individuals with virological failure on the TL+D regimen after 24 weeks of treatment (cases) to randomly selected individuals with viral control with viral load below the detection limits of 50 copies/mL, 24 weeks after treatment initiation (controls).
HYPOTHESIS: The central hypothesis is that transmitted drug resistance (TDR) may be associated with and contribute to virological failure with dolutegravir (DTG) in clinical practice. To test this central hypothesis, we will identify DTG-containing regimens with failure in people living with HIV in Brazil, a model country for large-scale DTG implementation, where multiple HIV subtypes cocirculate.
PRIMARY RESEARCH OBJECTIVE:
- Investigate the influence of transmitted drug resistance, the profile of HIV subtypes, and immunological and virological characteristics among individuals who failed the first-line TL+D regimen after 24 weeks of treatment in Brazil.
- Determine the genotypic resistance profile among individuals who failed first-line TL+D after 24 weeks of treatment in Brazil.
- Determine what alterations in the 3'-PPT are observed in viruses from patients failing TL+D and assess if this new resistance pathway contributes to acquired drug resistance in clinical practice.
RISK AND BENEFIT ASSESSMENT:
RISKS: The risks associated with this study include discomfort at the needle puncture site for blood draws or the possible appearance of a bruise. Discomfort or occasional bruising occur with the same frequency as any blood draw for exams that a patient is already accustomed to.
BENEFITS: Patients will receive no direct benefit from participation in this study. The resistance tests performed may eventually help in selecting more effective antiretroviral drugs if treatment is not fully effective in controlling the HIV in the body. There will be no financial costs or compensation for participation in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL+D | Active comparator | Drug: TL+D antiretroviralTL+D regimen of antiretroviral drugs for 24 weeks |
| Control | No intervention | –Individuals chosen who have not failed an HIV drug regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 70 ART therapy naive
Key exclusion criteria (1 listed)
- Resistant to reverse transcriptase inhibitor drugs (NRTI)
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 |
|---|---|---|
| TL+D antiretroviralPatients will receive the Tenofovir/Lamiduvine NRTI drugs along with the Dolutegravir for 24 weeks. | Drug | TL+D |
Primary outcome
Prevalence of TDR
Time frame: 3 months
Comparative analysis of transmitted drug resistance between arms of the study
4 secondary outcomes
Distribution of subtypes among regions
Time frame: 4 months
Sequence of 3'-PPT region of NEF
Time frame: 6 months
Viral Load
Time frame: 6 months
CD4+ Levels
Time frame: 6 months
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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. The sponsors plan to divulge all the anonymized data through a publicly available repository at a site to be determined.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TL+D antiretroviral in people with HIV and HIV -1 Infection, run by Federal University of São Paulo at 9 sites in Brazil.
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 1 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. 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?
Prevalence of TDR (time frame: 3 months). 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 10 Jun 2026.