EUCTR2016-005078-37-GR
Active, not recruiting
Phase 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 enrollmentMarch 29, 2017
DrugsTruvada
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
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:
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 4
The PrEDIRA StudyPACTR202109545700165Childrens Investment Fund Foundation400
Active, not recruiting
Phase 1
HIV prevention study with HIV-medicine in gay man in Belgium at high risk for acquiring HIV.HIV preventionTherapeutic area: Health Care [N] - Environment and Public Health [N06]EUCTR2015-000054-37-BEInstitute of Tropical Medicine200
Recruiting
Not Applicable
Implementation of HIV Pre-exposure Prophylaxis (PrEP) for men who have sex with men and transgender individuals at high risk for HIV infection: A Demonstration Project in the context of Combination Prevention in Brazil, Mexico and PeruMen who have sex with men (MSM) and transgender individuals (TG) who are at higher risk of acquiring HIV infection in Brazil, Mexico and PeruSP5.001.012.033.024.020M01.390RBR-4x3cnpInstituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz
Completed
Not Applicable
Public Health Targeting of PrEP at HIV Positives' Bridging NetworksHIVNCT02676167University of Chicago308
Recruiting
Phase 4
Person-centred public health for HIV treatment in ZambiaHIV/AIDSPACTR202101847907585Bill and Melinda Gates Foundation1,000