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

NCT01087840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-04-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Robert Fielden, RN · St Vincent's Hospital, Sydney

  • Anna McNulty, MBBS, FAChSHM · Sydney Sexual Health, Sydney Hospital

  • Phillip Read, MBBS, FAChSHM · Sydney Sexual Health, Sydney Hospital

  • Andrew Carr, MBBS, MD · St Vincents Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087840 on ClinicalTrials.gov