HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Kenneth H. Mayer, MD, Fenway Community Health

ClinicalTrials.gov Identifier:

NCT00594646

First received: January 7, 2008

Last updated: August 10, 2015

Last verified: August 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: TRUVADA + raltegravir	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate Raltegravir Truvada Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Kenneth H. Mayer, MD, Fenway Community Health:

Primary Outcome Measures:

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


Enrollment:	100
Study Start Date:	February 2008
Study Completion Date:	August 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1 TRUVADA + raltegravir	Drug: TRUVADA + raltegravir TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg Other Names: tenofovir DF emtricitabine

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594646

Locations


United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Fenway Community Health

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	Kenneth H Mayer, MD	Fenway Community Health

More Information

Additional Information:

Link to full-text publication This link exits the ClinicalTrials.gov site

Publications:

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.


Responsible Party:	Kenneth H. Mayer, MD, Medical Director, The Fenway Institute, Fenway Community Health
ClinicalTrials.gov Identifier:	NCT00594646 History of Changes
Other Study ID Numbers:	MK PEP 2007
Study First Received:	January 7, 2008
Results First Received:	August 10, 2015
Last Updated:	August 10, 2015

Keywords provided by Kenneth H. Mayer, MD, Fenway Community Health:


HIV Prevention Non-occupational post-exposure prophylaxis HIV seronegativity

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Raltegravir Potassium Emtricitabine	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Integrase Inhibitors Integrase Inhibitors

ClinicalTrials.gov processed this record on July 19, 2017

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