Clinical Trials

MainTitle

Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

This study has been completed
Sponsor
University of California, Los Angeles

Collaborator
Los Angeles County Department of Public Health
AIDS Project Los Angeles
Los Angeles LGBT Center
The OASIS Clinic

Information provided by (Responsible Party)
Dr. Raphael Landovitz, University of California, Los Angeles

ClinicalTrials.gov Identifier
NCT00949234

First received: July 29, 2009
Last updated: December 15, 2017
Last Verified: December 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Prevention
HIV Infections

Drug : tenofovir + emtricitabine, lopinavir/ritonavir
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Dr. Raphael Landovitz, University of California, Los Angeles:

Primary Outcome Measures

  • Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit [ Time Frame: 24 Weeks ]

Enrollment: 267
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Open-Label
This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.
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

    Other Name:
    • Truvada
    • Combivir

    Detailed Description:

    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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • Patients must be at least 18 years of age
    • Able to understand and provide consent
    • High-Risk Exposure Characteristic
    • (one or more of the below, unprotected or with failed condom use)
      • Receptive Anal Intercourse
      • Insertive Anal Intercourse
      • Receptive Vaginal Intercourse
      • Insertive Vaginal Intercourse
    • Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below)
      • Sharing injection drug works which have been intravascular
    • High-Risk Source (one or more of the below)
      • Known HIV positive
      • MSM
      • MSM/W
      • IDU
      • CSW
      • Sexual perpetrator
      • From an endemic country (prevalence >1%)
      • Partner of one of the above
    • Exposure within 72 hours of presentation
    • Not known to be HIV positive
    • No countermanding concomitant medications or allergies
    • HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).


    Exclusion Criteria:
    • Patients <18 years of age
    • Unable to understand and provide consent
    • Exposure >72 hours of presentation
    • Known to be HIV positive
    • Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms
    • Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including
      • adherence to PEP medication dosing
      • Demonstrated HIV-positive on rapid testing
      • Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure
      • Unwillingness of breast-feeding women to transition to formula feeding

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00949234

    Locations

    United States, California
    L.A. Gay & Lesbian Center
    Los Angeles, California, United States, 90028
    OASIS Clinic
    Los Angeles, California, United States, 90059

    Sponsors and Collaborators

    University of California, Los Angeles
    Los Angeles County Department of Public Health
    AIDS Project Los Angeles
    Los Angeles LGBT Center
    The OASIS Clinic

    Investigators

    Principal Investigator: Raphael J. Landovitz, M.D. University of California, Los Angeles
    More Information

    More Information


    Responsible Party: Dr. Raphael Landovitz, Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE), University of California, Los Angeles  
    ClinicalTrials.gov Identifier: NCT00949234   History of Changes  
    Other Study ID Numbers: PQUAD  
    Study First Received: July 29, 2009  
    Last Updated: December 15, 2017  

    Keywords provided by Dr. Raphael Landovitz, University of California, Los Angeles:

    post exposure prophylaxis
    biomedical prevention
    HIV seronegativity

    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Lopinavir
    Tenofovir
    Emtricitabine
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Lamivudine, zidovudine drug combination

    ClinicalTrials.gov processed this data on July 16, 2018
    This information is provided by ClinicalTrials.gov.