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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: AIDS Project Los Angeles; Los Angeles County Department of Public Health; Los Angeles LGBT Center; OASIS Clinic; The OASIS Clinic
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine, zidovudine drug combination; Lopinavir; Ritonavir; Tenofovir

Criteria

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