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

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ClinicalTrials.gov Identifier: NCT00949234
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE July 30, 2009
Results First Submitted Date  ICMJE October 2, 2017
Results First Posted Date  ICMJE December 18, 2017
Last Update Posted Date December 18, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Prevention
  • HIV Infections
Intervention  ICMJE 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 Names:
  • Truvada
  • Combivir
Study Arms  ICMJE 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.
Intervention: Drug: tenofovir + emtricitabine, lopinavir/ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
267
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2009)
100
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00949234
Other Study ID Numbers  ICMJE PQUAD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Raphael Landovitz, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • Los Angeles County Department of Public Health
  • AIDS Project Los Angeles
  • Los Angeles LGBT Center
  • The OASIS Clinic
Investigators  ICMJE
Principal Investigator: Raphael J. Landovitz, M.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP