At a glance
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The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment
In Brief
A Phase 3 clinical trial evaluating Emtricitabine/tenofovir disoproxil fumarate, Raltegravir, and 3 other interventions for HIV Infection. Completed, enrolled 1,814 participants across 57 sites in 2 countries.
Detailed Summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed. This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.
Study Details
Timeline
Interventions
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
400 mg taken orally twice daily. An integrase inhibitor (INI).
800 mg taken orally once daily. A protease inhibitor (PI).
100 mg taken orally once daily. A protease inhibitor (PI).
300 mg taken orally once daily. A protease inhibitor (PI).