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Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men (RAL-NPEP)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital
ClinicalTrials.gov Identifier:
NCT01087840
First received: March 15, 2010
Last updated: April 15, 2014
Last verified: April 2014
History of Changes
  Purpose

The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related to intrinsic qualities of the drugs used which includes at which point in the life cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated the drugs are i.e. what side effects they produce. Many people skip doses during their treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir works early in the life cycle of the virus i.e. before it integrates with human DNA, is potent against HIV and causes few side effects. These qualities make it an obvious choice for use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible sexual exposure to HIV. They will be monitored closely for adverse events, side effects and for their ability to take the medicine each day for the whole 28 days. The hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated and result in a high treatment completion rate.


Condition Intervention Phase
HIV Prevention
HIV Infections
 Drug: Raltegravir
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.
Enrollment: 120
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:
  • Isentress
  • Tenofovir disoproxil fumarate/emtricitabine

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

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087840

Locations
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
Sponsors and Collaborators
Andrew Carr
Merck Sharp & Dohme Corp.
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
  More Information

No publications provided by St Vincent's Hospital, Sydney

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew Carr, Professor, St Vincent's Hospital
ClinicalTrials.gov Identifier: NCT01087840     History of Changes
Other Study ID Numbers: RAL-NPEP version 1.
Study First Received: March 15, 2010
Last Updated: April 15, 2014
Health Authority: Australia: St. Vincent's Hospital Human Research Ethics Committee

Keywords provided by St Vincent's Hospital, Sydney:
HIV
nonoccupational
postexposure
prophylaxis
HIV Seronegativity

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015