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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew Carr
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Raltegravir Potassium; Tenofovir

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