Status:
COMPLETED
Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Los Angeles County Department of Public Health
AIDS Project Los Angeles
Conditions:
HIV Prevention
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 aft...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00949234
Start Date
March 1 2010
End Date
August 1 2011
Last Update
December 18 2017
Active Locations (2)
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1
L.A. Gay & Lesbian Center
Los Angeles, California, United States, 90028
2
OASIS Clinic
Los Angeles, California, United States, 90059