- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01087840
Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men (RAL-NPEP)
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
New South Wales
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Sydney, New South Wales, Australia, 2000
- Sydney Sexual Health, Sydney Hospital
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Sydney, New South Wales, Australia, 2010
- St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible MSM who, according to Australian NPEP guidelines, or in the opinion of the investigators, are assessed as eligible for NPEP following a potential or actual sexual exposure to HIV who present to St. Vincent's Hospital, Sydney.
Exclusion Criteria:
- Non sexual exposures
- Exposures occurring during sex between a man and a woman
- HIV infection diagnosed on baseline serological testing including indeterminate serology consistent with possible primary HIV infection
- Use of any medication contraindicated with RAL or TVD
- Serum hepatic transaminases (ALT/AST) greater than 5 times the upper limit of normal
- Serum creatinine greater than 2 times the upper limit of normal#
- Therapy with adefovir, tenofovir, emtricitabine, lamivudine, or entecavir for hepatitis B
- Baseline serological evidence of chronic/active hepatitis B
- Previous NPEP containing RAL in the study period
- A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. Arms: Raltegravir/Truvada |
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days on drug with 5 month follow-up
|
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
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28 days on-drug and 5 months follow-up
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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
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28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline visit day 1 of NPEP
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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)
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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.
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Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)
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To describe the effects of raltegravir and truvada on key inflammatory biomarkers
Time Frame: Day 1 and day 28 of NPEP
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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.
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Day 1 and day 28 of NPEP
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Tenofovir
- Emtricitabine
- Raltegravir Potassium
Other Study ID Numbers
- RAL-NPEP version 1.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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