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Study Compares First-Line Drug Therapies For Treating HIV

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The NRTI-sparing combination of lopinavir/ritonavir and efavirenz had never before been studied as first-line therapy in a large randomized clinical trial, in part because a general belief that combining an NNRTI with a protease inhibitor could result in resistance to two important classes of drugs. But earlier studies with other drug combinations suggested the approach would be safe. Thus, in designing the trial, Dr. Riddler and her national co-chair, Richard Haubrich, M.D., at the University of California, San Diego (UCSD) School of Medicine, felt it important to include this less conventional regimen so it could be evaluated under the rigors of a clinical trial.

The study included 753 participants at 55 centers and was conducted under the auspices of the AIDS Clinical Trials Group (ACTG), considered the world’s largest HIV clinical trials organization. ACTG receives its funding from the National Institute of Allergy and Infectious Diseases.

At the start of the study, just more than half of the participants had viral loads greater than 100,000 copies of HIV RNA per milliliter of blood. The median CD4+ T cell count was just 182 cells per cubic milliliter. Each participant was randomly assigned to one of the three treatment arms: 250 were selected to receive the efavirenz-based triple drug therapy, 253 the lopinavir/ritonavir-based triple drug therapy, and 250 were assigned to the group receiving the NRTI-sparing regimen of efavirenz and lopinavir/ritonavir. Participants in the triple-drug therapy groups each received two NRTIs: lamivudine, plus their choice of stavudine, zidovudine or tenofovir disoproxil fumarate.

The researchers found all three of the treatment regimens were potent, producing substantial increases in CD4+ T cell counts and decreases in HIV viral load. After 96 weeks of treatment, 89 percent of the participants randomized to the efavirenz arm had 'undetectable' levels of HIV, meaning viral load was less
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