At a glance
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International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen
In Brief
A clinical study evaluating Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate, and 3 other interventions for HIV Infections. Completed, enrolled 529 participants across 9 sites in 8 countries.
Detailed Summary
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.
Study Details
Timeline
Interventions
Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily
200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily
300-mg tablet taken orally once daily
300-mg tablet taken orally twice daily
200-mg tablet taken orally once daily