Long-acting intramuscular cabotegravir: Ph III HPTN 083 started

ViiV began the 3-step, double-blind, international Phase III HPTN 083 trial to compare 600 mg long-acting intramuscular cabotegravir vs. once-daily oral Truvada tenofovir disoproxil fumarate/emtricitabine in 4,500 men and transgender women who have sex with men and who are at high risk for HIV infection. In step 1, arm A will receive once-daily oral cabotegravir plus placebo for 5 weeks and arm B will receive Truvada plus placebo. Subjects that become infected with HIV will be terminated from the study. In step 2, arm A will receive 2 doses of long-acting intramuscular cabotegravir 4 weeks apart and a dose every 8 weeks thereafter plus placebo and arm B will receive Truvada plus placebo. Step 2 will continue until the required number of endpoints is reached and subjects that become infected with HIV will be terminated from the study. In step 3, all patients will receive Truvada no later than 8 weeks after their last injections for up to 48 weeks...