Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3

NCT04880395 | Completed Phase 4 Results

• 1 other identifier: FH 57
• Study Type: interventional
• Target: 265
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

HIV-1-infection

Keywords

antiretroviral naive triple therapy. Dolutegravir-Lamivudine; dual-therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 48

Secondary Outcomes (6)

• Antiviral Activity of DTG+3TC and DTG+TDF/XTC (TDF/FTC or TDF/3TC) at Week 24

  Week 24

• Safety and Tolerability of DTG+3TC and DTG+TDF/XTC Over Time

  week 48

• Antiviral Activity of DTG+3TC and DTG+TDF/XTC at Week 48 in Patients With Baseline Viral Load >100,000 c/mL

  Week 48

• Changes in Lymphocytes Subsets Between Baseline and 48 Weeks

  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

  week 48

Study Arms (2)

Experimental : Dolutegravir plus Lamivudine

EXPERIMENTAL

DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD

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

Drug: Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)

Interventions

Intervention Arm: dolutegravir/lamivudine DRUG

1 pill QD

Also known as: Dovato

Experimental : Dolutegravir plus Lamivudine

Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) DRUG

1 pill of each QD

active comparator : TDF/XTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Fundación Huésped: lead
• ViiV Healthcare: collaborator
• Federal University of Bahia: collaborator

Study Sites (11)

Fundación Huésped

Ciudad Autonoma de Buenos Aire, Buenos Aires, 1202, Argentina

Location

Hospital General de Agudos Dr. Cosme Argerich

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1155 AHD, Argentina

Location

Hospital de Infecciosas Francisco Javier Muñiz

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1282, Argentina

Location

Instituto CAICI

Rosario, Santa Fe Province, S2000, Argentina

Location

Hospital de Agudos J.A.Fernandez

Buenos Aires, C1425AGP, Argentina

Location

Fundação Bahiana de Infectologia

Salvador, Estado de Bahia, 40110-160, Brazil

Location

HUOC - Hospital Universitário Oswal do Cruz - Universidade de Pernambuco

Recife, Pernambuco, 50100-130, Brazil

Location

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Centro de Pesquisa: Instituto de Infectologia Emílio Ribas

Pacaembu, São Paulo, 01246-900, Brazil

Location

Centro de Treinamento e Referência DST/AIDS

São Paulo, 04121-000, Brazil

Location

Related Publications (1)

• 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. 2025 Aug 28:ciaf415. doi: 10.1093/cid/ciaf415. Online ahead of print.

  PMID: 40874763 DERIVED

MeSH Terms

Interventions

Lamivudine; dolutegravir; Emtricitabine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Results Point of Contact

• Title: Dr. María Inés Figueroa
• Organization: Fundación Huésped - Buenos Aires

maria.figueroa@huesped.org.ar

+54 11 2120-9999

Study Officials

• Maria Ines Figueroa, PI

  Fundación Huésped

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 10, 2021
• Study Start: May 17, 2021
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 month after last patient last visit
• Access Criteria: By request

Locations

BR (6); AR (5)