Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Recruitment status was: Recruiting
|HIV Transmission HIV Infections||Drug: tenofovir + emtricitabine, lopinavir/ritonavir||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County|
- To provide a comprehensive package of HIV prevention services, of which PEP can be an integral component.
- To evaluate the acceptability, feasibility, and safety of administering PEP in easily acceptable, non-judgmental, culturally, ethnically and linguistically appropriate environments.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: tenofovir + emtricitabine, lopinavir/ritonavir
The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen:
Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily
The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care.
In its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949234
|United States, California|
|L.A. Gay & Lesbian Center||Recruiting|
|Los Angeles, California, United States, 90028|
|Contact: Dustin Kerrone 323-993-7571|
|Los Angeles, California, United States, 90059|
|Contact: Collins Nwadiogbu 310-668-6038|
|Principal Investigator:||Raphael J. Landovitz, M.D.||University of California, Los Angeles|