Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT01214759
Eligibility Criteria:
Inclusion Criteria:
* Patients must be at least 18 years of age
* HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection
* 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
* High-Risk Source (One or more of the below):
* Known HIV positive
* MSM
* MSM/W
* CSW
* Sexual perpetrator Partner of one of the above
* Exposure within 72 hours of presentation
* Not known to be HIV-1 positive
* No countermanding concomitant medications or allergies
Exclusion Criteria:
* Patients \<18 years of age
* Unable to understand and provide consent
* Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure
* Known to be HIV positive
* 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 nPEP medication
* Demonstrated HIV-1 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
* Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures
* Pregnancy
* Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine or other therapy for hepatitis B
* Creatinine clearance less than 30 mL/min as calculated by Cockcroft-Gault formula
* Unwillingness to participate in study procedures, including Mental Health referral and intervention
* Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir
* Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01214759
Study Brief:
Protocol Section:
NCT01214759