HIV Non Occupational Post-Exposure Prophylaxis (PEP)

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: TRUVADA + Raltegravir

• Registration Number: NCT00594646
• Lead Sponsor: Fenway Community Health

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.

Study Timeline

• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Study Start: 2008-02
• Primary Completion: 2010-03
• Study Completion: 2010-08
• Results First Submitted: 2015-08-10
• Results First Submitted QC: 2015-08-10
• Results First Posted: 2015-09-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	TRUVADA + Raltegravir	TRUVADA

Primary Outcome Measures

Name	Time	Method
Medication Regimen Completion Rates	28 days	Pill counts performed at 14 and 28 days
Number of HIV-1 Infected Participants	90 days	Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected

Trial Locations

Locations (1)

Fenway Community Health; 🇺🇸 Boston, Massachusetts, United States