Healthy volunteers MedDRA version: 19.1 Level: PT Classification code 10020187 Term: HIV test negative System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Truvada
Product Name: Truvada (emtricitabine and tenofovir disoproxil fumarate)
Product Code: Truvada(emtricitabine&tenofovirdisoproxil fumarate
Sponsors
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
Eligibility
Sex/Gender
Male
Inclusion 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: o Patients 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable; Main Objective: 1)To identify the highest at risk HIV negative populations, that participate in local PWID networks (bridge networks), in which an infected person has been identified, and to administer PrEP to them. 2)To gather data on the early parameters in the PrEP cascade (HIV virus testing, connection to PrEP care, adherence to care and PrEP uptake, sexual behaviour and compliance with the therapy) in order to utilize this information in simulations and models regarding the effectiveness of PrEP as a public health intervention. Safety objective To assess the safety and tolerability of Truvada® during the study period. ; Primary end point(s): 1. Linkage to PrEP care including the first 2 visits within two weeks. 2. Missed visits proportion (MVP) during the treatment and follow-up periods of the study. 3. Treatment compliance measured as i) percentage of ingested doses (patient reported outcome, PRO), ii) days covered according to the drug dispensing logs. 4. Active substance concentration in Drug Blot Specimen (DBS) in months 3, 6, 9 and 12. ; Timepoint(s) of evaluation of this end point: 1. The first 2 visits within two weeks. 2. During the treatment and follow-up periods of the study. 3. Treatment compliance measured as i) percentage of ingested doses (patient reported outcome, PRO), ii) days covered according to the drug dispensing logs. 4. In months 3, 6, 9 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. HIV infections acquired between trial entry and 12th month. 2. Sexually transmitted infections acquired between trial entry and 12th month. 3. Reported number of stable and casual sex partners as evidenced by participants’ responses to interviewer-administered questionnaires at months 3, 6, 9, and 12. 4. Number of sexual partners with whom he had unprotected sex between trial entry and 12th month. 5. Number of acts of anal intercourse protected and unprotected by a condom, between trial entry and 12th month. 6. Assessment of ASSISTGR questionnaire (baseline and 12th month). 7. Assessment of BSIGR questionnaire (baseline and 12th month). 8. Assessment of Stigma Scale for HIV (baseline and 12th month). Safety outcome 1. The incidence of AE and SAE, nature, seriousness, relatedness and severity of AE during Truvada® administration. ; Timepoint(s) of evaluation of this end point: 1. Between trial entry and 12th month. 2. Between trial entry and 12th month. 3. At months 3, 6, 9, and 12. 4. Between trial entry and 12th month. 5. Between trial entry and 12th month. 6. Baseline and 12th month. 7. Baseline and 12th month. 8. Baseline and 12th month. Safety outcome 1. During Truvada® administration. | — |
Countries
Greece
Contacts
Public ContactClinical
Creative Pharma Services SA
Outcome results
None listed