Originally conceived in December, 2007, P-QUAD is now operational at 2 sites in epicenters of the HIV epidemic in Los Angeles: The Los Angeles Gay and Lesbian Center (opened March 2, 2010 in the Hollywood/West Hollywood area of Los Angeles with a largely MSM catchment), and The OASIS Clinic (opened April 15, 2010 in the south central area of Los Angeles with a largely lower socioeconomic status, at risk African-American and Latino catchment). The study provides dual or triple-agent ART for 28 days as post-exposure prophylaxis for HIV infection to individuals exposed sexually or via injection-drug works sharing, when presenting within 72 hours of an appropriately high-risk exposure. Additionally, substance use, mental health, and behavioral risk reduction referrals/linkages are provided as appropriate. Efficacy, safety, adherence, tolerability and behavioral outcomes are being collected. In the event of seroconversions, longitudinal specimens are stored for virologic analyses.
The program currently is providing Truvada (tenofovir + emtricitabine), or Combivir (zidovudine + lamivudine) with or without Kaletra (ritonavir + lopinavir). An upcoming amendment will offer Isentress (raltegravir) as an alternative to Kaletra for intolerance. An IND has been filed with the FDA for the use of these agents in a non-FDA approved study context (IND # 104,989) and the study is overseen and all study documents approved by the UCLA Institutional Review Board. Since opening the program, the P-QUAD has enrolled 30 participants as of May 6, 2010 [29 at LAGLC and 1 at OASIS], with an initially planned enrollment of 100 participants (50 at each site).