Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
NCT ID: NCT00949234
Last Updated: 2017-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2010-03-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Los Angeles County Department of Public Health
OTHER_GOV
AIDS Project Los Angeles
OTHER
Los Angeles LGBT Center
OTHER
The OASIS Clinic
UNKNOWN
University of California, Los Angeles
OTHER
Responsible Party
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Dr. Raphael Landovitz
Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE)
Principal Investigators
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Raphael J. Landovitz, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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L.A. Gay & Lesbian Center
Los Angeles, California, United States
OASIS Clinic
Los Angeles, California, United States
Countries
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Other Identifiers
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PQUAD
Identifier Type: -
Identifier Source: org_study_id