Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Condition: HIV Prevention; HIV Infections
MeSH terms: HIV Infections
Intervention: tenofovir + emtricitabine, lopinavir/ritonavir
Intervention description: 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
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post exposure prophylaxis; biomedical prevention; HIV seronegativity

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.
    

Eligibility 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