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
Sponsor study identifier
interventional
267
1 country
2
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
August 2011
Actual (reported)The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2009
Actual (reported)July 30, 2009
Actual (reported)March 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2010
Actual (reported)August 2011
Actual (reported)December 18, 2017
Actual (reported)Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit
24 Weeks
This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
tenofovir + emtricitabine, lopinavir/ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordL.A. Gay & Lesbian Center
Los Angeles, California, 90028, United States
OASIS Clinic
Los Angeles, California, 90059, United States
Open label clinical trial of deploying PEP regimens at community based sites. Non-randomized and guidelines have subsequently evolved.
Raphael J. Landovitz, M.D.
University of California, Los Angeles
267 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
A Randomized Controlled Trial of the Bruthas Project
Contact the study team to confirm eligibility.
Primary Completion
June 2010
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
December 18, 2017
Results First Posted
December 18, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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