Clinical trial NCT00594646: HIV Non Occupational Post-Exposure Prophylaxis (PEP)
Official title: A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV Prevention
Non-occupational post-exposure prophylaxis
HIV seronegativity
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Detailed description: This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Eligibility criteria: Inclusion Criteria:

* HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
* Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
* Able to understand the study procedures and willing to sign informed consent

Exclusion Criteria:

* Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
* Pregnancy.
* Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
* Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
* Unwillingness to participate in study procedures, including Mental Health referral and intervention.
* Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
* Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.

Primary outcomes:
measure: Medication Regimen Completion Rates
timeFrame: 28 days
measure: Number of HIV-1 Infected Participants
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Fenway Community Health
name: Kenneth H Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayer KH, Mimiaga MJ, Gelman M, Grasso C. Raltegravir, tenofovir DF, and emtricitabine for postexposure prophylaxis to prevent the sexual transmission of HIV: safety, tolerability, and adherence. J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):354-9. doi: 10.1097/QAI.0b013e31824a03b8.