HIV Non Occupational Post-Exposure Prophylaxis (PEP)
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ClinicalTrials.gov Identifier: NCT00594646 |
Recruitment Status
:
Completed
First Posted
: January 16, 2008
Results First Posted
: September 10, 2015
Last Update Posted
: September 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: TRUVADA + raltegravir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Group 1
TRUVADA + raltegravir
|
Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
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- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594646
United States, Massachusetts | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Kenneth H Mayer, MD | Fenway Community Health |
Additional Information:
Publications of Results:
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 |
First Posted: | January 16, 2008 Key Record Dates |
Results First Posted: | September 10, 2015 |
Last Update Posted: | September 10, 2015 |
Last Verified: | August 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 |