PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay me
- Conditions
- HIV infectionMedDRA version: 14.1 Level: PT Classification code 10054925 Term: Prophylaxis against HIV infection System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Health Care [N] - Environment and Public Health [N06]
- Registration Number
- EUCTR2012-002373-56-GB
- Lead Sponsor
- Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 544
1. Born to male gender, age 18 years or more 2. Previously attended the enrolling clinic on at least one occasion 3. Completed a screen for HIV and STIs 4. HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation 5. Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation 6. Likely, in the opinion of the volunteer, to have UAI in the next 90 days 7. Willing and able to comply with the visit schedule throughout the follow-up period 8. Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. An acute viral illness that could be due to HIV seroconversion 2. Any contraindications to Truvada according to the current package insert 3. Treatment for hepatitis B infection indicated or ongoing 4. Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method