HIV infection MedDRA version: 14.1 Level: PT Classification code 10054925 Term: Prophylaxis against HIV infection System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Truvada - clinical trial stock
Product Name: Truvada - clinical trial stock
Pharmaceutical Form: Tablet
INN or Proposed INN: tenofovir disop
Sponsors
Medical Research Council
Eligibility
Sex/Gender
Male
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this pilot is to determine whether it is feasibile to conduct a large trial in the UK to determine whether the immediate inclusion of anti-retroviral pre-exposure prophylaxis (PrEP) as part of the HIV risk reduction package for men who have sex with men is clinically effective and cost-effective in reducing the risk of acquiring HIV.;Secondary Objective: To assess the safety of daily Truvada in HIV negative individuals To assess whether gay men will take Truvada daily To determine whether sexual risk behaviour changes when taking PrEP, and if so, how To gain insight into - perceptions regarding risk of HIV and PrEP - facilitators and barriers to adopting methods to reduce the risk of HIV, including adherence to a daily tablet - the acceptability of study procedures including randomisation to no drug for the first year - understanding of the evidence for PrEP - understanding reasons for inconsistency between reported behaviour and biological data To determine the information that would be required to support the trial analyses, and the best methods to collect this.;Primary end point(s): This is a pilot study to determine the feasibility of a large scale HIV prevention trial. The main outcome is the ability to recruit and retain 500 participants as these two parameters will inform whether or not a large scale trial in the UK is feasible.;Timepoint(s) of evaluation of this end point: At least 12 months follow up for the last participant enrolled | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Two time periods are of interest for the analyses: - 0 to 12 months when half the participants will receive Truvada and half will not - 12 to 24 months when half the participants are receiving Truvada for the second year, and half for the first time;Secondary end point(s): HIV infection between randomisation and month 12 Quantitative safety outcome measures: - Serious Adverse Reactions attributable to Truvada - Adverse events that lead to interruption or cessation of Truvada - Renal function estimated using serum creatinine at 12m - Frequency of viral resistance in men who acquire HIV Quantitative adherence outcome measures: - Proportion of doses taken according to self-report - Proportion of days covered according to dispensing records - Presence of active drug in blood in a subset Quantitative risk compensation outcome measures: - Number of sexual partners with whom unprotected (insertive/receptive) anal intercourse takes place - Number of acts of anal intercourse, protected and unprotected - Proportion of acts of anal intercourse protected by either condom, PrEP or both - New STIs (urethral and rectal gonorrhoea or chlamydia, syphilis) Qualitative outcome measures (in a subset): - Perceptions of risk - Barriers and facilitators to reducing risk of HIV, and of other sexually transmitted infections - Barriers and facilitators to adherence to Truvada - Comprehension of the evidence for PrEP and instructions for taking drug - Acceptability of the study procedures including randomisation | — |
Countries
United Kingdom
Contacts
Public ContactPROUD trial team
Medical Research Council Clinical Trials Unit
Outcome results
None listed