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Clinical Trials/ISRCTN94465371
ISRCTN94465371Completed未知

PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV-negative gay men

Medical Research Council Clinical Trials Unit (MRC CTU) (UK)0 sites500 target enrollmentStarted: February 28, 2013Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
500

Study Overview

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
Male

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 sexually transmitted infections (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

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

Sponsor
Medical Research Council Clinical Trials Unit (MRC CTU) (UK)

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