HIV Non Occupational Post-Exposure Prophylaxis (PEP)

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594646
• Other study ID #: MK PEP 2007
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2022
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• TRUVADA + Raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fenway Community Health	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 1 — View Citation

Outcome

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

External Links

•   Link to full-text publication