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(MMA-0643) Safety and Efficacy of Once Daily Raltegravir (MK-0518) versus Twice Daily Raltegravir, Each in Combination with TRUVADA™, in Treatment-Naïve HIV Infected Subjects

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A Phase III, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) versus Twice Daily Raltegravir, Each in Combination with TRUVADA™, in Treatment-Naïve HIV

Principal Investigator:
Martin H. Markowitz M.D.


Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: (212) 327-7280
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
This is a research study to test whether taking the study drug Raltegravir, once a day (two 400 mg tablets taken together) is as safe and effective as taking it twice a day (one 400 mg tablet taken at two different times during the day approximately 10-14 hours apart). The study drug, Raltegravir, has been approved by the United States Food and Drug Administration (FDA) to help control HIV infection. Raltegravir is approved for use with other anti-HIV medicines in patients who are already taking or have taken anti-HIV medicines and the medicines are not controlling their HIV infection. The approved dose is one 400 mg tablet taken twice a day. Raltegravir is also known by the trade name, ISENTRESS™, or the study drug name, MK-0518.

Detailed Description of Protocol:
The primary objectives of this study are to evaluate the safety, tolerability and antiretroviral activity of once daily raltegravir in treatment-naïve HIV-infected patients. Once daily raltegravir (800 mg q.d., administered as two 400 mg tablets taken together once a day) will be compared with twice daily raltegravir (one 400 mg tablet b.i.d., administered as one 400 mg tablet taken 2 times a day), both given in combination with TRUVADA [a fixed-dose combination tablet containing 200 mg emtricitabine (+) 300 mg tenofovir disoproxil fumarate, Gilead Sciences]. Based on data from phase I studies and dose-ranging studies in treatment-naïve and treatment-experienced patients, raltegravir at a dose of 800 mg q.d. has been selected for use in this study. The raltegravir 800 mg q.d. regimen will be compared to the currently approved regimen of 400 mg b.i.d. This regimen has been demonstrated to be efficacious and generally well tolerated in two Phase III studies in treatment-experienced patients, and in a Phase II study, raltegravir 400 mg b.i.d. in combination with tenofovir and lamivudine was efficacious and generally well-tolerated in treatment-naïve HIV-infected patients. A Phase III study of raltegravir 400 mg b.i.d. in combination with TRUVADA in treatment-naïve HIV infected patients is ongoing. For the current study, TRUVADA was chosen as the nucleoside reverse transcriptase inhibitor (NRTI) component of the regimen since it has similar antiretroviral activity as tenofovir plus lamivudine, with simplified dosing.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• You are a male or female at least 18 years of age
• You are infected with HIV, the virus that causes AIDS
• Your HIV RNA viral load (the amount of virus in your blood) is more than 5000 within 45 days before the treatment phase of this study
• You are naïve to antiretroviral therapy (ART), meaning you have never taken anti-HIV medicines for more than 7 days and you have not taken any anti-HIV medicines within the 45 days before the treatment phase of this study
• You have certain laboratory results allowing you to be included in the study
• You have no signs or symptoms of active HIV infection at the time of entry into the study



Children permitted to participate:

Potential Benefits.....
Patients will receive HIV-1 medications and monitoring for safety and efficacy of the treatment regimen. If the research medication is effective in lowering the viral load subjects will benefit. If the research medication is not effective in lowering the viral load there may not be any benefit. Information learned from this study may help other people in the future.

Study participants will not receive financial compensation for participating in this study.