HivNCT06393387
Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States
An observational study of Hiv and HIV-1-infection, run by Midway Specialty Care Center at 1 site in United States.
Trial summary
This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, HIV-1-infection, HIV Infections
- What is being tested?
- DTG/3TC versus BIC/F/TAF
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: PWH from all 12 sites in Florida across Midway Specialty Care Center.
Who may be able to join
- Adults, aged 18 years and older;
- Diagnosis of HIV-1;
- Have a history of ART consisting of DTG/3TC or BIC/F/TAF, initiated from May 1, 2019 through January 28, 2023;
- Have at least 48 weeks of clinical follow up after initiation of DTG/3TC or BIC/F/TAF; clinical follow-up can include time post-discontinuation of either index regimen;
- Complete data, for HIV-1 RNA viral load at all study time points, including baseline, through 24 weeks and through 48 weeks;
- Received care from a physician, nurse practitioner or physician assistant at the organization
Who cannot join
- Index regimen is BIC/F/TAF and has a history of ART consisting of DTG+3TC or DTG/3TC;
- Index regimen is DTG/3TC and has a history of ART consisting of BIC/F/TAF
Trial locations and contacts
1 site in 1 country.
United States1 site
Midway Specialty Care Center
West Palm Beach, Florida, 33401
About this study
Official title: Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States (REVIVE Study)
This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States
Read the detailed description
3-drug regimens (3DR) have been the foundation of HIV treatment for the last two decades; however, based on more recent data from GEMINI 1 and 2, TANGO, SALSA and STAT clinical trials, 2-drug regimens (2DR), such as dolutegravir/lamivudine, have shown similar efficacy in viral suppression as compared to 3DR1,2,5,6. Furthermore, real-world evidence (RWE) data has reinforced the clinical trial data, showing similar effectiveness outcomes data of DTG/3TC vs. 3DR across ~38,000 people living with HIV, in a variety of sub-populations, including more than 1,200 who are ART naïve. Test and treat strategies have also been successful with both 2DR and 3DR3, but analysis of clinical outcomes, including barriers to resistance as evidenced by viral suppression, in persons with more challenging to treat HIV (PWH), are needed, including PWH with social determinant of health (SDOH) indicators (including but not limited to unstable housing, food insecurity, unemployment, uninsured and/or unstable transportation). PWH may prioritize addressing these needs over adherence to antiretroviral therapy and lower adherence to antiretroviral therapy raises the concern for lack of viral suppression and/or the development of resistance.
A recent study demonstrated that PWH in the United States with 2 or more SDOH indicators were 20% less likely to report excellent adherence in the prior 30 days and 10% less likely to achieve sustained viral suppression in the prior year4 . Furthermore, as HIV disproportionately affects persons of lower socioeconomic status who are experiencing multiple SDOH indicators, identifying ART that can be used to achieve viral suppression in this patient population is essential.
This retrospective study will be performed across a not-for-profit multi-clinic infectious disease organization in the Southeast United States comprising 12 clinics. This multi-clinic infectious disease organization provided care to over 6,000 PWH over the last 5 years. 25% of those PWH identified as cisgender females. 60% of the total PWH were ages 50 years and older. Over 50% of PWH identified their race as a racial and/or ethnic minority.
10 out of 12 clinics are located in 5 of Florida's 6 top counties for prevalence of persons with HIV (Miami-Dade, Broward, Orange, Palm Beach, and Hillsborough Counties). 6 out of 12 clinics provide care for persons with HIV with Ryan White (persons with federal poverty level below 400%). Clinics across the organization provide rapid entry to care for PWH to enter care for the first time (treatment naïve) and/or re-enter care, after being out of care and/or off of ART. The rapid entry to care model also provides the opportunity to review clinical outcomes of PWH starting on either 2DR or 3DR who are re-entering care with an unknown history of resistance.
- Conditions
- Hiv, HIV-1-infection, HIV Infections
- Being tested
- DTG/3TC versus BIC/F/TAF
- Keywords
- HIV, Social Determinants of Health, Adherence, Viral Suppression, Percent of Days Covered
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTG/3TC versus BIC/F/TAFDrug
A new-user, active comparator, retrospective cohort study design will be employed using inverse probability of treatment weighting to adjust for measured confounders. This study will be conducted as a retrospective chart review and the organization's electronic health record (EHR) will be utilized. Subjects identified as having previously been or currently receiving DTG/3TC or BIC/F/TAF will be assessed for eligibility based on inclusion/exclusion criteria. Subject eligibility will be confirmed by the Principal Investigator (PI).
| Study group | Role | What they receive |
|---|---|---|
| Persons with HIV on DTG/3TC | All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study. Receives: Drug: DTG/3TC versus BIC/F/TAF | |
| Persons with HIV on BIC/F/TAF | All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study. Receives: Drug: DTG/3TC versus BIC/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
To evaluate the effectiveness of switching treatment to DTG/3TC vs. BIC/F/TAF through 48 weeks in virally suppressed ART experienced individuals with no interruptions in prior therapy.
Measured: 48 Weeks
Secondary outcomes (8)
Viral Suppression
To evaluate the effectiveness of switching treatment to DTG/3TC vs. BIC/F/TAF through 24 weeks in virally suppressed ART experienced individuals with no interruptions in prior therapy.
Measured: 24 Weeks
Viral Suppression
To evaluate the effectiveness of DTG/3TC vs. BIC/F/TAF through 48 weeks in ART naïve individuals (i.e., no prior ART regimen received).
Measured: 48 Weeks
Viral Suppression
To evaluate the effectiveness of DTG/3TC vs. BIC/F/TAF through 24 weeks in ART naïve individuals.
Measured: 24 Weeks
Viral Suppression
To evaluate the effectiveness of DTG/3TC vs. BIC/F/TAF through 48 weeks in ART experienced individuals who are returning to care (i.e., previous ART therapy received but not in the last month).
Measured: 48 Weeks
Viral Suppression
To evaluate the effectiveness of DTG/3TC vs. BIC/F/TAF through 24 weeks in ART experienced individuals who are returning to care.
Measured: 24 Weeks
Clinical Characteristics of Persons with HIV
To describe the baseline demographics and clinical characteristics of individuals on DTG/3TC and BIC/F/TAF by the following sub-groups: (1) Virally suppressed, (2) ART experienced individuals, \& (3) ART naïve individuals ART experienced individuals who are returning to care
Measured: Baseline
Tolerability
To assess the tolerability (i.e., all drug-related adverse reactions (ARs) as per label) of DTG/3TC vs. BIC/F/TAF through 24 weeks and 48 weeks by the following sub-groups: (1) Virally suppressed ART experienced individuals, (2) ART naïve individuals \& (3) ART experienced individuals who are returning to care.
Measured: 24, 48 Weeks
Treatment Discontinuation
To assess treatment discontinuations (i.e., withdrawals due to drug-related ARs) of DTG/3TC vs. BIC/F/TAF through 24 weeks and 48 weeks by the following sub-groups: (1) Virally suppressed ART experienced individuals, (2) ART naïve individuals, (3) ART experienced individuals who are returning to care.
Measured: 24, 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midway Specialty Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Kuretski, Midway Specialty Care Center
- Investigators
- Jennifer Kuretski, DNP, Principal investigator, Midway Specialty Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393387
- Sponsor's protocol ID
- 222132
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.
PubMed 30420123Cahn P, Sierra Madero J, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man CY, Urbaityte R, Brandon DJ, Underwood M, Pappa KA, Curtis L, Smith KY, Gartland M, Aboud M, van Wyk J, Wynne B. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy - naive adults with HIV-1 infection. AIDS. 2022 Jan 1;36(1):39-48. doi: 10.1097/QAD.0000000000003070.
PubMed 34534138Menza TW, Hixson LK, Lipira L, Drach L. Social Determinants of Health and Care Outcomes Among People With HIV in the United States. Open Forum Infect Dis. 2021 Jun 22;8(7):ofab330. doi: 10.1093/ofid/ofab330. eCollection 2021 Jul.
PubMed 34307729van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.
PubMed 31905383Maggiolo F, Valenti D, Teocchi R, Comi L, Filippo ED, Rizzi M. Adherence to and Forgiveness of 3TC/DTG in a Real-World Cohort. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221101815. doi: 10.1177/23259582221101815.
PubMed 35695220Maggiolo F , MD, Valenti D , BSc, Teocchi R , BSc, Comi L , MD, Di Filippo E , MD, Rizzi M , MD. Real World Data on Forgiveness to Uncomplete Adherence to Bictegravir/ Emtricitabine/Tenofovir Alafenamide. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221140208. doi: 10.1177/23259582221140208.
PubMed 36423244Rolle CP, Berhe M, Singh T, Ortiz R, Wurapa A, Ramgopal M, Leone PA, Matthews JE, Dalessandro M, Underwood MR, Angelis K, Wynne BR, Merrill D, Nguyen C, van Wyk J, Zolopa AR. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021 Oct 1;35(12):1957-1965. doi: 10.1097/QAD.0000000000002979.
PubMed 34115650
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States (REVIVE Study)
- ClinicalTrials.gov ID
- NCT06393387
- Acronym / sponsor ID
- 222132
- Conditions
- Hiv, HIV-1-infection, HIV Infections
- Keywords
- HIV, Social Determinants of Health, Adherence, Viral Suppression, Percent of Days Covered
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Midway Specialty Care CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 1 May 2024 (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 real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States
Detailed description
3-drug regimens (3DR) have been the foundation of HIV treatment for the last two decades; however, based on more recent data from GEMINI 1 and 2, TANGO, SALSA and STAT clinical trials, 2-drug regimens (2DR), such as dolutegravir/lamivudine, have shown similar efficacy in viral suppression as compared to 3DR1,2,5,6. Furthermore, real-world evidence (RWE) data has reinforced the clinical trial data, showing similar effectiveness outcomes data of DTG/3TC vs. 3DR across ~38,000 people living with HIV, in a variety of sub-populations, including more than 1,200 who are ART naïve. Test and treat strategies have also been successful with both 2DR and 3DR3, but analysis of clinical outcomes, including barriers to resistance as evidenced by viral suppression, in persons with more challenging to treat HIV (PWH), are needed, including PWH with social determinant of health (SDOH) indicators (including but not limited to unstable housing, food insecurity, unemployment, uninsured and/or unstable transportation). PWH may prioritize addressing these needs over adherence to antiretroviral therapy and lower adherence to antiretroviral therapy raises the concern for lack of viral suppression and/or the development of resistance.
A recent study demonstrated that PWH in the United States with 2 or more SDOH indicators were 20% less likely to report excellent adherence in the prior 30 days and 10% less likely to achieve sustained viral suppression in the prior year4 . Furthermore, as HIV disproportionately affects persons of lower socioeconomic status who are experiencing multiple SDOH indicators, identifying ART that can be used to achieve viral suppression in this patient population is essential.
This retrospective study will be performed across a not-for-profit multi-clinic infectious disease organization in the Southeast United States comprising 12 clinics. This multi-clinic infectious disease organization provided care to over 6,000 PWH over the last 5 years. 25% of those PWH identified as cisgender females. 60% of the total PWH were ages 50 years and older. Over 50% of PWH identified their race as a racial and/or ethnic minority.
10 out of 12 clinics are located in 5 of Florida's 6 top counties for prevalence of persons with HIV (Miami-Dade, Broward, Orange, Palm Beach, and Hillsborough Counties). 6 out of 12 clinics provide care for persons with HIV with Ryan White (persons with federal poverty level below 400%). Clinics across the organization provide rapid entry to care for PWH to enter care for the first time (treatment naïve) and/or re-enter care, after being out of care and/or off of ART. The rapid entry to care model also provides the opportunity to review clinical outcomes of PWH starting on either 2DR or 3DR who are re-entering care with an unknown history of resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with HIV on DTG/3TC | – | Drug: DTG/3TC versus BIC/F/TAFAll data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study. |
| Persons with HIV on BIC/F/TAF | – | Drug: DTG/3TC versus BIC/F/TAFAll data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PWH from all 12 sites in Florida across Midway Specialty Care Center.
Key inclusion criteria (6 listed)
- Adults, aged 18 years and older;
- Diagnosis of HIV-1;
- Have a history of ART consisting of DTG/3TC or BIC/F/TAF, initiated from May 1, 2019 through January 28, 2023;
- Have at least 48 weeks of clinical follow up after initiation of DTG/3TC or BIC/F/TAF; clinical follow-up can include time post-discontinuation of either index regimen;
- Complete data, for HIV-1 RNA viral load at all study time points, including baseline, through 24 weeks and through 48 weeks;
Key exclusion criteria (2 listed)
- Index regimen is BIC/F/TAF and has a history of ART consisting of DTG+3TC or DTG/3TC;
- Index regimen is DTG/3TC and has a history of ART consisting of BIC/F/TAF
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 |
|---|---|---|
| DTG/3TC versus BIC/F/TAFA new-user, active comparator, retrospective cohort study design will be employed using inverse probability of treatment weighting to adjust for measured confounders. This study will be conducted as a retrospective chart review and the organization's electronic health record (EHR) will be utilized. Subjects identified as having previously been or currently receiving DTG/3TC or BIC/F/TAF will be assessed for eligibility based on inclusion/exclusion criteria. Subject eligibility will be confirmed by the Principal Investigator (PI). | Drug | Persons with HIV on BIC/F/TAF, Persons with HIV on DTG/3TC |
Primary outcome
Viral Suppression
Time frame: 48 Weeks
To evaluate the effectiveness of switching treatment to DTG/3TC vs. BIC/F/TAF through 48 weeks in virally suppressed ART experienced individuals with no interruptions in prior therapy.
8 secondary outcomes
Viral Suppression
Time frame: 24 Weeks
Viral Suppression
Time frame: 48 Weeks
Viral Suppression
Time frame: 24 Weeks
Viral Suppression
Time frame: 48 Weeks
Viral Suppression
Time frame: 24 Weeks
Clinical Characteristics of Persons with HIV
Time frame: Baseline
Tolerability
Time frame: 24, 48 Weeks
Treatment Discontinuation
Time frame: 24, 48 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 26 Sep 2025.
- Results publication: PubMed 30420123Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.
- Results publication: PubMed 34534138Cahn P, Sierra Madero J, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man CY, Urbaityte R, Brandon DJ, Underwood M, Pappa KA, Curtis L, Smith KY, Gartland M, Aboud M, van Wyk J, Wynne B. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy - naive adults with HIV-1 infection. AIDS. 2022 Jan 1;36(1):39-48. doi: 10.1097/QAD.0000000000003070.
- Results publication: PubMed 34307729Menza TW, Hixson LK, Lipira L, Drach L. Social Determinants of Health and Care Outcomes Among People With HIV in the United States. Open Forum Infect Dis. 2021 Jun 22;8(7):ofab330. doi: 10.1093/ofid/ofab330. eCollection 2021 Jul.
- Results publication: PubMed 31905383van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.
- Results publication: PubMed 35695220Maggiolo F, Valenti D, Teocchi R, Comi L, Filippo ED, Rizzi M. Adherence to and Forgiveness of 3TC/DTG in a Real-World Cohort. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221101815. doi: 10.1177/23259582221101815.
- Results publication: PubMed 36423244Maggiolo F , MD, Valenti D , BSc, Teocchi R , BSc, Comi L , MD, Di Filippo E , MD, Rizzi M , MD. Real World Data on Forgiveness to Uncomplete Adherence to Bictegravir/ Emtricitabine/Tenofovir Alafenamide. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221140208. doi: 10.1177/23259582221140208.
- Results publication: PubMed 34115650Rolle CP, Berhe M, Singh T, Ortiz R, Wurapa A, Ramgopal M, Leone PA, Matthews JE, Dalessandro M, Underwood MR, Angelis K, Wynne BR, Merrill D, Nguyen C, van Wyk J, Zolopa AR. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021 Oct 1;35(12):1957-1965. doi: 10.1097/QAD.0000000000002979.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jennifer Kuretski, DNP principal investigator
Midway Specialty Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and HIV-1-infection, run by Midway Specialty Care Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 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 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: 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 NCT06393387, which also lists 7 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 26 Sep 2025.