E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Health Care [N] - Environment and Public Health [N06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054925 |
E.1.2 | Term | Prophylaxis against HIV infection |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At least 12 months follow up for the last participant enrolled |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Intensified combination interventions to reduce risk alone |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 29 |