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
Brief Summary
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26364263 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27013513 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31826890 (added 13/12/2019)
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
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