EUCTR2012-002373-56-GBActive, not recruitingPhase 1
PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men - PROUD
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medical Research Council
- Enrollment
- 544
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. 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
Exclusion Criteria
- •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
Investigators
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