Outcomes of Dolutegravir Treatment for HIV in Brazil
Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study
This study looks at how well a new HIV treatment called dolutegravir works for different groups of patients in Brazil over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundação Bahiana de Infectologia Academic / other |
| Locations | 3 sites (Salvador, Bahia and 2 other locations) |
| Trial ID | NCT04326504 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes of patients with HIV starting a dolutegravir (DTG)-based antiretroviral therapy (ART) regimen in Brazil. It will follow three groups of patients: those who are ART-naïve starting DTG, those switching to DTG from stable ART, and those switching due to virological failure. Additionally, a retrospective control group of patients who initiated non-DTG-based ART will be included for comparison. The study will track these patients over a period of 36 months to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15 and older with documented HIV infection who are starting a DTG-based regimen or were on non-DTG ART between 2014 and 2016.
Not a fit: Patients who have previously used ART or are currently imprisoned will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of dolutegravir-based regimens for treating HIV, potentially improving treatment protocols.
How similar studies have performed: Other studies have shown positive outcomes with dolutegravir-based regimens, indicating a promising approach in HIV treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salvador, Bahia and 2 other locations
- Fundação Bahiana de Infectologia/SEI — Salvador, Bahia, Brazil (Recruiting)
- Fundação Bahiana de Infectologia — Salvador, Ba, Brazil (Recruiting)
- Centro de Referência e Treinamento — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Carlos Brites, MD, PhD
- Email: crbrites@gmail.com
- Phone: 557132838123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.