NCT07618507

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
777

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

May 25, 2026

Last Update Submit

June 8, 2026

Conditions

HIVHIV -1 Infection

Keywords

DTGTDRtransmitted drug resistancesubtype

Outcome Measures

Primary Outcomes (1)

  • Prevalence of TDR

    Comparative analysis of transmitted drug resistance between arms of the study

    3 months

Secondary Outcomes (4)

  • Distribution of subtypes among regions

    4 months

  • Sequence of 3'-PPT region of NEF

    6 months

  • Viral Load

    6 months

  • CD4+ Levels

    6 months

Study Arms (2)

TL+D

ACTIVE COMPARATOR

TL+D regimen of antiretroviral drugs for 24 weeks

Drug: TL+D antiretroviral

Control

NO INTERVENTION

Individuals chosen who have not failed an HIV drug regimen

Interventions

TL+D antiretroviralDRUG

Patients will receive the Tenofovir/Lamiduvine NRTI drugs along with the Dolutegravir for 24 weeks.

TL+D

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 ART therapy naive

You may not qualify if:

  • Resistant to reverse transcriptase inhibitor drugs (NRTI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Fundação de Medicina Tropical Doutor Heitor Vieira Dourado

Manaus, Amazonas, 69040-000, Brazil

Location

Centro Estadual Especializado em Diagnóstico, Assistência e Pesquisa (CEDAP)

Salvador, Estado de Bahia, 40100-160, Brazil

Location

Centro Especializado em Doenças Infecciosas (CEDIN-DF)

Brasília, Federal District, 70351-580, Brazil

Location

LADI - Laboratório de Apoio Diagnóstico em Infectologia (Hospital Universitário Miguel Riet Corrêa Jr)

Porto Alegre, Rio Grande do Sul, 90040-000, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Serviço Especializado em IST/HIV/AIDS Viamão

Viamão, Rio Grande do Sul, 94480-560, Brazil

Location

Unidade de Infectologia William Rocha

Guarujá, São Paulo, 11471-000, Brazil

Location

Retrovirology Laboratory - UNIFESP

São Paulo, São Paulo, 04039-032, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Livre Docente in the Infectology Discipline of the Department of Medicine of Escola Paulista de Medicina /UNIFESP.

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

April 13, 2022

Primary Completion

March 8, 2024

Study Completion

March 8, 2024

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The sponsors plan to divulge all the anonymized data through a publicly available repository at a site to be determined.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The IPD will be available by June 2026 and stay publicly available for 10 years (until May 2036).
Access Criteria
Access will be publicly available and include all the data from the project. Access will be by accessing the public repository.

Locations

BR(9)