HIV-1-infectionPhase 4DOLCENCT04880395
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
A Phase 4 study testing Intervention Arm: dolutegravir/lamivudine and Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) in people with HIV-1-infection, run by Fundación Huésped at 11 sites in 2 countries.
Trial summary
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Intervention Arm: dolutegravir/lamivudine and Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 May 2021to 7 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions.
- Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasma HIV-1 RNA (>1,000 copies/mL) or a positive western blot. A previous result performed on the last 30 days can be used.
- ≥18 years of age
- Naïve to ARV therapies (defined as ≤ 10 days of prior therapy with any antiretroviral therapy following an HIV diagnosis). Previous use of PrEP or PEP is allowed if there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis.
- HIV RNA at screening visit > or = 1,000 copies/mL. A previous result performed on the last 30 days can be used.
- CD4 at screening < or = 200 cells/mL A previous result performed on the last 30 days can be used.
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- Subjects can comply with protocol requirements.
- Subject agrees not to take any medication during the study, including over-the-counter medicines or herbal preparations, without the approval of the trial physician.
- Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the study.
- A female may be eligible to enter and participate in the study if she is not pregnant (as confirmed by serum pregnancy test negative at screening, and a urine negative test at baseline), not lactating and at least one of the following condition applies:
- Women with non-reproductive potential, defined as pre-menospausal females with documented tubal ligation or hysterectomy, or bilateral oophorectomy; or as post-menospausal women defined as 12 months of spontaneous amenorrhea, and ≥45 years of age in women without hormonal replacement therapy.
- Women with reproductive potential and agrees to follow one of the contraceptive options listed in the Appendix 3 from at least 15 days prior to the first dose of medication and until at least 30 days after the last dose of study medication and completion of the follow-up visit.
- Any contraception method must be used consistently, in accordance with the approved product label. All subjects participating in the study should be counselled on safer sexual practices including the use of effective barrier methods and the choice of effective contraceptive method should be documented in the eCRF.
Who cannot join
- Women who are pregnant or breastfeeding, or women who plan to become pregnant in the next year.
- Subjects testing positive for Hepatitis B surface antigen (+HBsAg) at screening, or anticipated need for Hepatitis C virus (HCV) therapy with drugs with potential drug-drug interaction during the study.
- Subjects with severe hepatic impairment (Child-Pugh class C), or unstable liver disease (ascites, encephalopathy, coagulopathy, or oesophageal or gastric varices) or cirrhosis.
- Opportunistic infections that impede to start ART immediately (specifically tuberculosis, meningeal tuberculosis or cryptococcosis within the first month of specific treatment). Subjects with other suspected or confirmed active opportunistic infections and subjects with cryptococcal disease after the initial period can be included if she/he can follow the protocol and if her/his participation could benefit the subject. A clear documentation of these aspects must to be done in the clinical chart of the participant.
- Subjects who in the investigator's judgment, pose a significant suicidality risk.
- History or presence of allergy to the study drugs or their components or drugs of their class
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- Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses; or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening; or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product.
- Any previous evidence of resistance to dolutegravir (defined as the presence of G118R, Q148 H/K/R or R263K), to lamivudine (presence of the mutation M184V) or resistance to tenofovir (mutation K65R or more than 3 TAMs) with a Sanger sequence method or using next-generation sequencing (NGS) at a frequency >15%. If the subject does not have a previous resistance test, samples will be taken at the screening visit and the subject can be randomized and start the study. while awaiting the results (see section 4.8).
- Any verified Grade 4 abnormality.
- Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin).
- Creatinine clearance of <50mL/min via Cockroft-Gault method.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Brazil6 sites
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, 26030-380
Centro de Pesquisa: Instituto de Infectologia Emílio Ribas
Pacaembu, São Paulo, 01246-900
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
HUOC - Hospital Universitário Oswal do Cruz - Universidade de Pernambuco
Recife, Pernambuco, 50100-130
Fundação Bahiana de Infectologia
Salvador, Estado de Bahia, 40110-160
Centro de Treinamento e Referência DST/AIDS
São Paulo, 04121-000
Argentina5 sites
Hospital de Agudos J.A.Fernandez
Buenos Aires, C1425AGP
Fundación Huésped
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1202
Hospital General de Agudos Dr. Cosme Argerich
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1155 AHD
Hospital de Infecciosas Francisco Javier Muñiz
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1282
Instituto CAICI
Rosario, Santa Fe Province, S2000
About this study
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3
Protocol Number: FH-57
Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.
Read the detailed description
Primary endpoint: Proportion of patients with viral load < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Secondary Objectives:
- To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 24
- To evaluate the safety and tolerability of DTG+3TC and DTG+TDF/XTC over time
- To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 48 in patients with baseline viral load >100,000 c/mL
- To evaluate immunological activity (CD4+ lymphocyte [CD4 counts]) at Week 24 and Week 48
- To assess the development of HIV-1 resistance in patients with virologic failure or viral rebound treated with DTG+3TC or DTG+TDF/XTC
- To evaluate the incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG + 3TC and DTG + TDF/XTC over time.
Secondary endpoints:
- Proportion of patients treated with DTG+3TC and DTG+TDF/XTC with HIV-1 levels of less than 50 copies/mL at week 24
- Frequency, type and severity of adverse events and laboratory abnormalities and proportion of patients who discontinue DTG+3TC or DTG+TDF/XTC due to adverse events or death
- Proportion of patients with baseline HIV-1 RNA >100,000 c/mL that achieve virological suppression at week 48 weeks,
- Changes in CD4 count, CD8 count and CD4/CD8 ratio between baseline and 48 weeks
- Number and type of resistance mutations in case of virologic failure (defined as a confirmed viral above 200 copies/mL after week 24 copies/mL or viral rebound at any timepoint)
- Incidence of IRIS and disease progression (HIV associated conditions, AIDS and death).
Tertiary objectives:
● TDF/XTCTo explore change in health-related quality-of-life for subjects treated with DTG plus 3TC and DTG + TDF/XTC
Tertiary endpoints:
● Change from Baseline in health-related quality of life using EQ-5D-5L and PHQ9 at Weeks 24, and 48
Patient Population:
HIV-1-infected subjects aged >18 years who are naïve to antiretroviral therapy with ≤200 CD4 cell/mm3
Study Design:
Prospective, Phase IV, randomized, multicenter, parallel group study design
Regimens:
Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg.
Duration: 48 weeks
Sample size:230 subjects
- Conditions
- HIV-1-infection
- Being tested
- Intervention Arm: dolutegravir/lamivudine, Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Keywords
- antiretroviral naive triple therapy. Dolutegravir-Lamivudine, dual-therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Arm: dolutegravir/lamivudineDrug
Also called Dovato
1 pill QD
Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)Drug
1 pill of each QD
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Dolutegravir plus Lamivudine | Experimental | DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD Receives: Drug: Intervention Arm: dolutegravir/lamivudine |
| active comparator : TDF/XTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine) | Active comparator | Unit Dose:
* TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
* TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD Receives: Drug: Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3.
Percentage of patients with viral load < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Measured: Week 48
Secondary outcomes (6)
Antiviral Activity of DTG+3TC and DTG+TDF/XTC (TDF/FTC or TDF/3TC) at Week 24
Percentage of patients treated with DTG+3TC and DTG+TDF/XTC with HIV-1 levels of less than 50 copies/mL at week 24
Measured: Week 24
Safety and Tolerability of DTG+3TC and DTG+TDF/XTC Over Time
Percentage of patients who discontinue treatment due to adverse events or death
Measured: week 48
Antiviral Activity of DTG+3TC and DTG+TDF/XTC at Week 48 in Patients With Baseline Viral Load >100,000 c/mL
Percentage of patients with baseline viral load >100,000 c/mL that reach HIV-1 levels of less than 50 copies/mL at week 48
Measured: Week 48
Changes in Lymphocytes Subsets Between Baseline and 48 Weeks
Changes in lymphocytes CD4 cells count per mL
Measured: Week 48
Development of HIV-1 Resistance in Patients With Virologic Failure or Viral Rebound Whilst Being Treated With DTG+3TC or DTG+TDF/XTC
Number and type of resistance mutations in case of virologic failure (defined as a confirmed viral above 200 copies/mL on or after week 24 or confirmed viral rebound at any timepoint)
Measured: week 48
Incidence of IRIS or Disease Progression (HIV Associated Conditions, AIDS and Death).
Evaluation of disease progression incidence (HIV-associated conditions, AIDS and death) with DTG+3TC and DTG + TDF/XTC treatment over time
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start17 May 2021
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Federal University of Bahia
- Responsible party
- Principal investigator, Maria Ines Figueroa, Fundación Huésped
- Investigators
- Maria Ines Figueroa, PI, Principal investigator, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880395
- Sponsor's protocol ID
- FH 57
- Acronym
- DOLCE
- Status last verified
- Jul 2025
- First submitted
- 26 Apr 2021
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD available upon request. The request should be supported with a hypothesis-driven project, that should include analysis plan
Publications
Figueroa MI, Brites C, Cecchini D, Ramalho A, Francos JL, Lacerda M, Rolon MJ, Madruga JV, Sprinz E, Souza TNL, Parenti P, Converso D, Mernies G, Sued O, Cahn P; DOLCE study group. Efficacy and Safety of Dual Therapy With Dolutegravir/Lamivudine in Treatment-naive Persons With CD4 Counts <200/mm3: 48-Week Results of the DOLCE Study. Clin Infect Dis. 2026 Feb 9;82(1):122-131. doi: 10.1093/cid/ciaf415.
PubMed 40874763
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
- ClinicalTrials.gov ID
- NCT04880395
- Acronym / sponsor ID
- DOLCE / FH 57
- Conditions
- HIV-1-infection
- Keywords
- antiretroviral naive triple therapy. Dolutegravir-Lamivudine, dual-therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Federal University of Bahia
- Study start
- 17 May 2021 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 30 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3
Protocol Number: FH-57
Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.
Detailed description
Primary endpoint: Proportion of patients with viral load < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Secondary Objectives:
- To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 24
- To evaluate the safety and tolerability of DTG+3TC and DTG+TDF/XTC over time
- To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 48 in patients with baseline viral load >100,000 c/mL
- To evaluate immunological activity (CD4+ lymphocyte [CD4 counts]) at Week 24 and Week 48
- To assess the development of HIV-1 resistance in patients with virologic failure or viral rebound treated with DTG+3TC or DTG+TDF/XTC
- To evaluate the incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG + 3TC and DTG + TDF/XTC over time.
Secondary endpoints:
- Proportion of patients treated with DTG+3TC and DTG+TDF/XTC with HIV-1 levels of less than 50 copies/mL at week 24
- Frequency, type and severity of adverse events and laboratory abnormalities and proportion of patients who discontinue DTG+3TC or DTG+TDF/XTC due to adverse events or death
- Proportion of patients with baseline HIV-1 RNA >100,000 c/mL that achieve virological suppression at week 48 weeks,
- Changes in CD4 count, CD8 count and CD4/CD8 ratio between baseline and 48 weeks
- Number and type of resistance mutations in case of virologic failure (defined as a confirmed viral above 200 copies/mL after week 24 copies/mL or viral rebound at any timepoint)
- Incidence of IRIS and disease progression (HIV associated conditions, AIDS and death).
Tertiary objectives:
● TDF/XTCTo explore change in health-related quality-of-life for subjects treated with DTG plus 3TC and DTG + TDF/XTC
Tertiary endpoints:
● Change from Baseline in health-related quality of life using EQ-5D-5L and PHQ9 at Weeks 24, and 48
Patient Population:
HIV-1-infected subjects aged >18 years who are naïve to antiretroviral therapy with ≤200 CD4 cell/mm3
Study Design:
Prospective, Phase IV, randomized, multicenter, parallel group study design
Regimens:
Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg.
Duration: 48 weeks
Sample size:230 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Dolutegravir plus Lamivudine | Experimental | Drug: Intervention Arm: dolutegravir/lamivudineDOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD |
| active comparator : TDF/XTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine) | Active comparator | Drug: Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)Unit Dose: * TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR * TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions.
- Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasma HIV-1 RNA (>1,000 copies/mL) or a positive western blot. A previous result performed on the last 30 days can be used.
- ≥18 years of age
- Naïve to ARV therapies (defined as ≤ 10 days of prior therapy with any antiretroviral therapy following an HIV diagnosis). Previous use of PrEP or PEP is allowed if there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis.
- HIV RNA at screening visit > or = 1,000 copies/mL. A previous result performed on the last 30 days can be used.
Key exclusion criteria (11 listed)
- Women who are pregnant or breastfeeding, or women who plan to become pregnant in the next year.
- Subjects testing positive for Hepatitis B surface antigen (+HBsAg) at screening, or anticipated need for Hepatitis C virus (HCV) therapy with drugs with potential drug-drug interaction during the study.
- Subjects with severe hepatic impairment (Child-Pugh class C), or unstable liver disease (ascites, encephalopathy, coagulopathy, or oesophageal or gastric varices) or cirrhosis.
- Opportunistic infections that impede to start ART immediately (specifically tuberculosis, meningeal tuberculosis or cryptococcosis within the first month of specific treatment). Subjects with other suspected or confirmed active opportunistic infections and subjects with cryptococcal disease after the initial period can be included if she/he can follow the protocol and if her/his participation could benefit the subject. A clear documentation of these aspects must to be done in the clinical chart of the participant.
- Subjects who in the investigator's judgment, pose a significant suicidality risk.
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 |
|---|---|---|
| Intervention Arm: dolutegravir/lamivudineAlso: Dovato1 pill QD | Drug | Experimental : Dolutegravir plus Lamivudine |
| Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)1 pill of each QD | Drug | active comparator : TDF/XTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine) |
Primary outcome
Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3.
Time frame: Week 48
Percentage of patients with viral load < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
6 secondary outcomes
Antiviral Activity of DTG+3TC and DTG+TDF/XTC (TDF/FTC or TDF/3TC) at Week 24
Time frame: Week 24
Safety and Tolerability of DTG+3TC and DTG+TDF/XTC Over Time
Time frame: week 48
Antiviral Activity of DTG+3TC and DTG+TDF/XTC at Week 48 in Patients With Baseline Viral Load >100,000 c/mL
Time frame: Week 48
Changes in Lymphocytes Subsets Between Baseline and 48 Weeks
Time frame: Week 48
Development of HIV-1 Resistance in Patients With Virologic Failure or Viral Rebound Whilst Being Treated With DTG+3TC or DTG+TDF/XTC
Time frame: week 48
Incidence of IRIS or Disease Progression (HIV Associated Conditions, AIDS and Death).
Time frame: week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40874763Figueroa MI, Brites C, Cecchini D, Ramalho A, Francos JL, Lacerda M, Rolon MJ, Madruga JV, Sprinz E, Souza TNL, Parenti P, Converso D, Mernies G, Sued O, Cahn P; DOLCE study group. Efficacy and Safety of Dual Therapy With Dolutegravir/Lamivudine in Treatment-naive Persons With CD4 Counts <200/mm3: 48-Week Results of the DOLCE Study. Clin Infect Dis. 2026 Feb 9;82(1):122-131. doi: 10.1093/cid/ciaf415.
- Individual participant dataSharing planned: Yes. IPD available upon request. The request should be supported with a hypothesis-driven project, that should include analysis plan
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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.
Maria Ines Figueroa, PI principal investigator
Fundación Huésped
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention Arm: dolutegravir/lamivudine and Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) in people with HIV-1-infection, run by Fundación Huésped at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, Argentina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3. (time frame: Week 48). 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 NCT04880395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.