Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men (RAL-NPEP)
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|ClinicalTrials.gov Identifier: NCT01087840|
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention HIV Infections||Drug: Raltegravir||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||July 2012|
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
- 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 ]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 ]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 ]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 ]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) ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087840
|Australia, New South Wales|
|Sydney Sexual Health, Sydney Hospital|
|Sydney, New South Wales, Australia, 2000|
|St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst|
|Sydney, New South Wales, Australia, 2010|
|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|