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Multi-center Study to Evaluate Virological Efficacy, Safety Tolerability, Drug Exposure and Patients' Reported Outcomes Over 48 Weeks Following Randomization to 2-drug Therapy With DTG/3TC FDC or Continuing Current Antiretroviral Tenofovir (TAF or TDF)-Containing Regimen (T-CR) in HIV-1 Infected Virologically Suppressed
Strategies for optimizing antiretroviral treatment in virologically suppressed patients are still a major challenge in the field of HIV. These strategies include improving the toxicity and tolerability of drugs in the short and long term, such as replacing toxic agents with safer ones or reducing the number of drugs in the combination. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that is converted intracellularly to the active form, resulting in higher concentrations of TFV diphosphate in circulating lymphocytes than those obtained with tenofovir disoproxil fumarate (TDF). Because of these pharmacokinetic properties, TAF results in 91% lower plasma exposure to TFV. Phase 3 studies have established the virological noninferiority of TAF to TDF, with a lower frequency of renal and bone adverse events. Replacing TDF with TAF may be a safe and effective option to reduce toxicities when switching from one ARV strategy to another and, to date, could represent the optimization of a three-drug regimen. Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Fondazione PoliclinicoAgostino Gemelli IRCCS
Roma, Italy
Start Date
October 1, 2023
Primary Completion Date
September 15, 2025
Completion Date
September 15, 2025
Last Updated
September 13, 2023
290
ESTIMATED participants
Antiviral Agents
DRUG
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT04142047
NCT06694805
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428330