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

NCT01087840 | Completed Phase 4

• 1 other identifier: RAL-NPEP version 1.
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Prevention; HIV Infections

Keywords

HIV; nonoccupational; postexposure; prophylaxis; HIV Seronegativity

Outcome Measures

Primary Outcomes (3)

• To describe the safety of 28 days of nonoccupational post-exposure prophylaxis containing raltegravir

  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

  Subjective reporting of AEs with data collection/grading utilising DAIDS-AE

  28 days on-drug and 5 months follow-up

• To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing raltegravir

  Adherence measurement by self report and pill count at 3 time points during the 28-days of NPEP

  28 days

Secondary Outcomes (3)

• To describe the context of the risk

  Baseline visit day 1 of NPEP

• To investigate whether or not receipt of NPEP decreases, increases or has no impact on future HIV risk taking behaviour

  Visit 2 (day 3-5 of study), visit 7 (day 82-84 of study) visit 9 (day 166-168 of study)

• To describe the effects of raltegravir and truvada on key inflammatory biomarkers

  Day 1 and day 28 of NPEP

Study Arms (1)

Raltegravir, NPEP

EXPERIMENTAL

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

Interventions

Raltegravir DRUG

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

Also known as: Isentress, Tenofovir disoproxil fumarate/emtricitabine

Raltegravir, NPEP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Carr: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Sydney Sexual Health, Sydney Hospital

Sydney, New South Wales, 2000, Australia

Location

St. Vincent's Hospital, 390 Victoria Rd, Darlinghurst

Sydney, New South Wales, 2010, Australia

Location

Related Publications (1)

• McAllister J, Carr A. Should a protease inhibitor be standard of care for HIV postexposure prophylaxis? AIDS. 2011 Mar 13;25(5):721-2. doi: 10.1097/QAD.0b013e32834168bd. No abstract available.

  PMID: 21368592 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

AU (2)