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Search / Trial NCT04326504

Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil

Launched by FUNDAÇÃO BAHIANA DE INFECTOLOGIA · Mar 26, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Dolutegravir (DTG) on people living with HIV in Brazil. The researchers want to find out how well DTG works for both new patients who have never received HIV treatment before and those who have been treated but are now starting a new regimen. They will compare the results of patients taking DTG with those who started a different type of HIV treatment between 2014 and 2016. This information is important because it helps healthcare providers understand the best treatment options for patients.

To participate in the trial, you must be at least 15 years old and have a confirmed HIV infection. If you're a woman who could become pregnant, you'll need to agree to use effective birth control. You cannot have taken any HIV medications before if you want to be in the group starting DTG for the first time. Participants will need to sign a consent form and may have regular check-ins to monitor their health and the effectiveness of the treatment. This study is currently recruiting participants, and your involvement could contribute valuable information to improve HIV treatment options in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Signed informed consent.
  • HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
  • Age ≥ 15 years.
  • For women of child-bearing potential, willingness to use effective contraceptives.
  • Starting use of DTG-based regimen, or being initiated on a non-DTG based ART between 2014 - 2016.
  • Exclusion Criteria:
  • • Any previous use of ART (drug-naïve group only).
  • Current imprisonment, or compulsory detention (involuntary incarceration). For treatment of a psychiatric or physical illness.

About Fundação Bahiana De Infectologia

Fundação Bahiana de Infectologia is a leading Brazilian research foundation dedicated to advancing the field of infectious diseases through innovative clinical trials and public health initiatives. With a commitment to improving health outcomes, the foundation collaborates with academic institutions, healthcare providers, and international organizations to conduct rigorous scientific research. Its mission encompasses the development and evaluation of novel therapeutic approaches, vaccines, and prevention strategies aimed at combating infectious diseases prevalent in Brazil and beyond. The foundation is recognized for its expertise in clinical trials and its contribution to evidence-based practices in infectious disease management.

Locations

Salvador, Bahia, Brazil

Salvador, Ba, Brazil

São Paulo, Sp, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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