Status:
COMPLETED
Tripe Versus Dual Antiretroviral Therapy in HIV-infected Patients With Virological Suppression (Tridual)
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The persistence of an aberrant state of immune activation and inflammation (pIA) may contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in HIV-infected patients...
Detailed Description
Primary Outcome Measures: to evaluate the changes in the CD4/CD8 ratio, immune activation and other immunologic parameters at 48 weeks after switching to dual therapy based on dolutegravir plus emtric...
Eligibility Criteria
Inclusion
- HIV-1-infected patients ≥ 18 years of age.
- Starting date of antiretroviral treatment later than 01/01/2010
- Plasma HIV-1 RNA \<20 copies/ml for at least one year on triple therapy
- Antiretroviral treatment based on an integrase inhibitor plus two nucleos(t)ide analogs in the last 6 months.
- Signed written informed consent prior to inclusion.
Exclusion
- Primary resistance to any of the drugs included in the study.
- Active opportunistic infection.
- Pregnancy at inclusion or during the follow-up
- Active hepatitis C and/or B virus co-infection.
- Cirrhosis, portal hypertension and/or hypersplenism of any etiology.
- Current or past malignancies subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
- Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS.
- Concomitant use of drugs with potential major interactions with the prescribed drugs according to the respective full prescribing information.
- Estimated creatinine clearance \<50 ml/min
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03447873
Start Date
June 1 2017
End Date
February 3 2021
Last Update
August 30 2021
Active Locations (1)
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1
Virgen del Rocio University Hospital
Seville, Spain, 41013