Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men (RAL-NPEP)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis|
- To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir [ Time Frame: 28 days on drug with 5 month follow-up ] [ Designated as safety issue: Yes ]Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight and vital signs, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate, urinalysis
- To describe the tolerability of 28 days of NPEP containing raltegravir [ Time Frame: 28 days on-drug and 5 months follow-up ] [ Designated as safety issue: Yes ]Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
- To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir [ Time Frame: 28 days ] [ Designated as safety issue: No ]Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP
- To describe the context of the risk [ Time Frame: Baseline visit day 1 of NPEP ] [ Designated as safety issue: No ]Context of risk event described using directed questioning around pre determined variables
- To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour [ Time Frame: Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study) ] [ Designated as safety issue: No ]Baseline data collection of HIV risk behaviour in 6 months preceeding NPEP. Repeat data collection at week 12 and week 24 post NPEP risk event. Data collected utilising assisted completion of HIV related behaviour questionaire.
- To describe the effects of raltegravir and truvada on key inflammatory biomarkers [ Time Frame: Day 1 and day 28 of NPEP ] [ Designated as safety issue: No ]Measurement of CR-P, D-Dimer, IL-6 on a subset of 50 patients receiving raltegravir/truvada NPEP and a subset of 25 patients receiving truvada alone as NPEP.
|Study Start Date:||July 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Raltegravir, NPEP
Drug: Raltegravir Tablet 400mg taken orally, twice daily with or without food for 28 days along with Truvada 1 tablet taken orally daily for 28 days.
Drug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days.
Arms: Raltegravir/Truvada Other Names: Isentress/Truvada
This is a single site, 72-week, prospective, open-label, non-randomized trial. One hundred and 50 (150) eligible participants will be assigned to receive RAL 400 mg BID along with tenofovir disoproxil fumarate/emtricitabine (TVD) 1 tablet once daily (3-drug NPEP) for 28-days or TVD 1 tablet once daily (2-drug NPEP) for 28-days according to established Australian guidelines for the use of 3 or 2-drug NPEP following a potential or actual sexual exposure to HIV in men who have sex with men (MSM).1 Based on hospital NPEP data over the past 2 years, it is anticipated that 100 MSM will receive 3-drug (RAL-TVD) NPEP and 50 will receive 2-drug (TVD) NPEP. Follow-up post NPEP is for 23 weeks i.e. to week 24 post exposure.
Primary study objectives:
To describe the safety of 28 days of nonoccupational post-exposure prophylaxis(NPEP) containing raltegravir (RAL) To describe the tolerability of 28 days of NPEP containing RAL To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing RAL
Secondary study objectives:
To investigate whether or not receipt of NPEP decreases, increases or has no impact on HIV risk taking behaviour To describe the effects of RAL and tenofovir disoproxil fumarate/emtricitabine (TVD) on key inflammatory biomarkers in a subset of the main study population
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087840
|Australia, New South Wales|
|St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst|
|Sydney, New South Wales, Australia, 2010|
|Sydney Sexual Health, Sydney Hospital|
|Sydney, New South Wales, Australia, 2000|
|Principal Investigator:||Robert Fielden, RN||St Vincent's Hospital, Sydney|
|Principal Investigator:||Anna McNulty, MBBS, FAChSHM||Sydney Sexual Health, Sydney Hospital|
|Principal Investigator:||Phillip Read, MBBS, FAChSHM||Sydney Sexual Health, Sydney Hospital|
|Principal Investigator:||Andrew Carr, MBBS, MD||St Vincents Hospital|