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

Completed · Phase 2

Conditions studied: HIV Prevention, HIV Infections

In brief

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.

Key facts

Study ID

NCT00949234

Run by

University of California, Los Angeles

People needed

267

Starts

2010-03-01

Expected to finish

2011-08-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• L.A. Gay & Lesbian Center — Los Angeles, California, United States
• OASIS Clinic — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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