EUCTR2016-005078-37-GRActive, not recruitingPhase 1
Public health targeting of PrEP at HIV positives’ bridging networks
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases0 sites100 target enrollmentStarted: March 29, 2017Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Born to male gender, age 18 years or more.
- •2. Documented negative HIV antibody test(s) immediately before starting PrEP medication (up until 3 days before commencement of therapy).
- •3. Completed screen for STIs (syphilis, gonorrhoea, chlamydia).
- •4. Confirm that the patient is at substantial, ongoing, high risk for acquiring HIV infection in the past 6 months:
- •oPatients with sexual (MSM, MSMTF) or intravenous drug use risks for acquiring HIV should be considered for starting the PrEP medication.
- •Sexual risk includes (1) condomless anal sex with =2 male or transgender female partners; (2) =2 episodes of anal sex with at least 1 HIV-infected partner; or (3) sex with a male or transgender female partner and self-reported history of syphilis, rectal gonorrhoea, or rectal chlamydia.
- •5. Confirm that the patient’s” calculated creatinine clearance is greater than or equal to 60 mL/minute (via Cockcroft-Gault formula).
- •6. Willing and able to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. An acute viral illness that could be due to a primary HIV infection syndrome.
- •2. Any contraindications to Truvada® according to the current package insert.
- •3. Treatment for hepatitis B infection, ongoing or programmed.
- •4. Administration (current or expected) of a treatment that may be toxic to the kidneys (long-term anti-inflammatory use).
- •5. Serious disease which could require a treatment that could disrupt the compliance to PrEP.
- •6. Participation in other interventional clinical trials 30 days prior to enrolment in the present clinical study.
- •7. Inability or unwillingness to comply to study protocol requirement adjunct to primary objectives.
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