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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949234
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
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

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.

Condition or disease Intervention/treatment Phase
HIV Prevention HIV Infections Drug: tenofovir + emtricitabine, lopinavir/ritonavir Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: N/A
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
Study Start Date : March 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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 Names:
  • Truvada
  • Combivir

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949234

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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
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Principal Investigator: Raphael J. Landovitz, M.D. University of California, Los Angeles
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Responsible Party: Dr. Raphael Landovitz, Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE), University of California, Los Angeles Identifier: NCT00949234    
Other Study ID Numbers: PQUAD
First Posted: July 30, 2009    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: December 2017
Keywords provided by Dr. Raphael Landovitz, University of California, Los Angeles:
post exposure prophylaxis
biomedical prevention
HIV seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors