HIV-1-infectionREDOLANCT04638686
REal-Life Cohort With DOlutegravir + LAmivudina
An observational study of HIV-1-infection, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dolutegravir 50 MG and Lamivudine 300 MG
- How many people
- 185 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2020to 31 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is an open, multicenter and prospective cohort of HIV-infected adult patients who have initiated Dolutegravir/lamivudine as first line treatment for HIV-1 infection prior to be included in study. We hope to include 200 patients. Patient management will be according to the standard of care. We will collect data related to efficacy, tolerance, and discontinuations due any reasons (lost to follow-up, withdrawal of consent, switching,..). We will carry out an analysis by intention to treat according to the snapshot criteria defined by the FDA ±12 weeks window in the context of routine clinical practice (±2 weeks in w-4 analysis), considering as virological failure those patients who discontinue the treatment for any reason, loss to follow-up, withdraw informed consent or those who die for causes unrelated to the treatment
Who may be able to join
- Patient ≥ 18 years of age diagnosed with HIV.
- Naïve antiretroviral treatment with dolutegravir/lamivudine initiated between July 2018 and March 2020.
- Patients who agree to participate and sign the informed consent form of the study
- Patients lost to follow up or died prior to the inclusion in the study (Ethics Committee agreement for exemption from obtaining informed consent in these cases).
Who cannot join
- Patient < 18 years of age.
- Patients who don't agree to participate and don't sign the informed consent.
- Current pregnancy or breastfeeding.
- No effective contraception for FRP women.
- Evidence of DTG or 3TC resistance genotype*
- Hepatitis B (HBV) infection
Show all 9Show fewer
- Severe hepatic impairment or unstable liver disease
- Moderate to severe renal impairment
- AIDS defining illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study
Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term antiretroviral therapy (ART). Two-drug regimens (2DRs) have been investigated as a means for reducing the number of antiretroviral agents (ARVs) taken by individuals who need lifelong ART. Dovato® (Dolutegravir/lamivudine) has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US Food and Drug Administration (FDA) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato ® as an initial treatment in HIV-naÏve patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients.
Our results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with dolutegravir (DTG) + lamivudine (3TC), to verify efficacy and tolerance in real life. Our hypothesis is that the data will be similar to those reported in clinical trials.
Read the detailed description
Our primary objective of this study is to analyze the proportion of individuals (HIV naïve patients) who has initiated 3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h), and who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48.
Secondary objectives are: to analyze the proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 24 and 96, to describe absolute values and changes from ART initiation in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks, Changes from ART initiation in creatinine clearance anda fasting lipids at weeks 24, 48 and 96, and the proportion of subjects who discontinue treatment and reasons for discontinuations
- Conditions
- HIV-1-infection
- Being tested
- Dolutegravir 50 MG, Lamivudine 300 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50 MGDrug
The subjects started their antiretroviral treatment containing dolutegravir once a day.
Lamivudine 300 MGDrug
The subjects started their antiretroviral treatment containing lamivudine once a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48
HIV-1 RNA ≤50 copies/mL at 48 weeks
Measured: 48 weeks
Secondary outcomes (6)
Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 24 and 96
HIV-1 RNA ≤50 copies/mL at 24 and 96 weeks
Measured: weeks 24 and 96
Absolute values and changes from ART initiation in CD4+ cells count at 24, 48 and 96 weeks
CD4 (cel/μL) at weeks 0, 24,48 and 96
Measured: weeks 24, 48 and 96
Absolute values and changes from ART initiation in CD4:CD8 ratio at 24, 48 and 96
CD4/CD8 (ratio) at weeks 0, 24,48 and 96
Measured: weeks 24, 48 and 96
Changes from ART initiation in creatinine clearance at weeks 24, 48 and 96.
creatinine clearance (mg/dL) at weeks 0, 24, 48 and 96.
Measured: weeks 24, 48 and 96
Changes from ART initiation in fasting lipids (total cholesterol, HDL cholesterol, LDL) cholesterol, triglycerides and ratio of total cholesterol to HDL cholesterol) at weeks 24, 48 and 96
total cholesterol, HDL cholesterol, LDL (mg/dL) at weeks 0, 24, 48 and 96.
Measured: weeks 24, 48 and 96
Proportion of subjects who discontinue treatment and reasons for discontinuations
number of subjects who discontinue treatment and reasons for these discontinuations
Measured: weeks 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Jun 2020
- Primary completion15 Jun 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638686
- Sponsor's protocol ID
- IFJD-DOL-20-01
- Acronym
- REDOLA
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2020
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 30420123Radford M, Parks DC, Ferrante S, Punekar Y. Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. AIDS. 2019 Sep 1;33(11):1739-1749. doi: 10.1097/QAD.0000000000002285.
PubMed 31180906van 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 31905383Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.
PubMed 29293895Joly V, Burdet C, Landman R, Vigan M, Charpentier C, Katlama C, Cabie A, Benalycherif A, Peytavin G, Yeni P, Mentre F, Argoud AL, Amri I, Descamps D, Yazdanpanah Y; LAMIDOL Study Group. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019 Mar 1;74(3):739-745. doi: 10.1093/jac/dky467.
PubMed 30476165Cabello-Ubeda A, Lopez Bernardo de Quiros JC, Mena A, Torralba M, Martin Carbonero L, Gutierrez A, Vergas J, Pinto A, Tejerina F, Palmier E, Sanz J, Gorgolas M, Pulido F. Dolutegravir (DTG) + Lamivudine (3 TC) in Antiretroviral-Naive Adults With HIV With and Without Genotypic Resistance Testing Results: 96-Week Effectiveness and Tolerability of REDOLA Study. J Acquir Immune Defic Syndr. 2025 Oct 1;100(2):e4-e7. doi: 10.1097/QAI.0000000000003721. No abstract available.
PubMed 40673705
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study
- ClinicalTrials.gov ID
- NCT04638686
- Acronym / sponsor ID
- REDOLA / IFJD-DOL-20-01
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 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.
Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term antiretroviral therapy (ART). Two-drug regimens (2DRs) have been investigated as a means for reducing the number of antiretroviral agents (ARVs) taken by individuals who need lifelong ART. Dovato® (Dolutegravir/lamivudine) has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US Food and Drug Administration (FDA) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato ® as an initial treatment in HIV-naÏve patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients.
Our results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with dolutegravir (DTG) + lamivudine (3TC), to verify efficacy and tolerance in real life. Our hypothesis is that the data will be similar to those reported in clinical trials.
Detailed description
Our primary objective of this study is to analyze the proportion of individuals (HIV naïve patients) who has initiated 3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h), and who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48.
Secondary objectives are: to analyze the proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 24 and 96, to describe absolute values and changes from ART initiation in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks, Changes from ART initiation in creatinine clearance anda fasting lipids at weeks 24, 48 and 96, and the proportion of subjects who discontinue treatment and reasons for discontinuations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is an open, multicenter and prospective cohort of HIV-infected adult patients who have initiated Dolutegravir/lamivudine as first line treatment for HIV-1 infection prior to be included in study. We hope to include 200 patients. Patient management will be according to the standard of care. We will collect data related to efficacy, tolerance, and discontinuations due any reasons (lost to follow-up, withdrawal of consent, switching,..). We will carry out an analysis by intention to treat according to the snapshot criteria defined by the FDA ±12 weeks window in the context of routine clinical practice (±2 weeks in w-4 analysis), considering as virological failure those patients who discontinue the treatment for any reason, loss to follow-up, withdraw informed consent or those who die for causes unrelated to the treatment
Key inclusion criteria (4 listed)
- Patient ≥ 18 years of age diagnosed with HIV.
- Naïve antiretroviral treatment with dolutegravir/lamivudine initiated between July 2018 and March 2020.
- Patients who agree to participate and sign the informed consent form of the study
- Patients lost to follow up or died prior to the inclusion in the study (Ethics Committee agreement for exemption from obtaining informed consent in these cases).
Key exclusion criteria (9 listed)
- Patient < 18 years of age.
- Patients who don't agree to participate and don't sign the informed consent.
- Current pregnancy or breastfeeding.
- No effective contraception for FRP women.
- Evidence of DTG or 3TC resistance genotype*
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 |
|---|---|---|
| Dolutegravir 50 MGThe subjects started their antiretroviral treatment containing dolutegravir once a day. | Drug | – |
| Lamivudine 300 MGThe subjects started their antiretroviral treatment containing lamivudine once a day | Drug | – |
Primary outcome
Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48
Time frame: 48 weeks
HIV-1 RNA ≤50 copies/mL at 48 weeks
6 secondary outcomes
Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 24 and 96
Time frame: weeks 24 and 96
Absolute values and changes from ART initiation in CD4+ cells count at 24, 48 and 96 weeks
Time frame: weeks 24, 48 and 96
Absolute values and changes from ART initiation in CD4:CD8 ratio at 24, 48 and 96
Time frame: weeks 24, 48 and 96
Changes from ART initiation in creatinine clearance at weeks 24, 48 and 96.
Time frame: weeks 24, 48 and 96
Changes from ART initiation in fasting lipids (total cholesterol, HDL cholesterol, LDL) cholesterol, triglycerides and ratio of total cholesterol to HDL cholesterol) at weeks 24, 48 and 96
Time frame: weeks 24, 48 and 96
Proportion of subjects who discontinue treatment and reasons for discontinuations
Time frame: weeks 48 and 96
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 14 Nov 2023.
- Background: 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.
- Background: PubMed 31180906Radford M, Parks DC, Ferrante S, Punekar Y. Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. AIDS. 2019 Sep 1;33(11):1739-1749. doi: 10.1097/QAD.0000000000002285.
- Background: 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.
- Background: PubMed 29293895Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.
- Background: PubMed 30476165Joly V, Burdet C, Landman R, Vigan M, Charpentier C, Katlama C, Cabie A, Benalycherif A, Peytavin G, Yeni P, Mentre F, Argoud AL, Amri I, Descamps D, Yazdanpanah Y; LAMIDOL Study Group. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019 Mar 1;74(3):739-745. doi: 10.1093/jac/dky467.
- Derived from this study: PubMed 40673705Cabello-Ubeda A, Lopez Bernardo de Quiros JC, Mena A, Torralba M, Martin Carbonero L, Gutierrez A, Vergas J, Pinto A, Tejerina F, Palmier E, Sanz J, Gorgolas M, Pulido F. Dolutegravir (DTG) + Lamivudine (3 TC) in Antiretroviral-Naive Adults With HIV With and Without Genotypic Resistance Testing Results: 96-Week Effectiveness and Tolerability of REDOLA Study. J Acquir Immune Defic Syndr. 2025 Oct 1;100(2):e4-e7. doi: 10.1097/QAI.0000000000003721. No abstract available.
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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.
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-1-infection, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 4 inclusion and 9 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 14 Nov 2023. 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 Spain. 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 of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48 (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 NCT04638686, which also lists 6 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 14 Nov 2023.