A study to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Phase 1

• Conditions: Healthy volunteers; MedDRA version: 19.1 Level: PT Classification code 10020187 Term: HIV test negative System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-005078-37-GR
• Lead Sponsor: Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified