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(MMA-0761) A Phase 3b Randomized, Open-Label Study in Virologically-Suppressed, HIV-1 Infected Patients (GS-US 236-0121)


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A Phase 3b Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients (GS-US 236-0121)

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:
Saurabh Mehandru M.D.
Sharon Karmon MD, MPH
Teresa Evering M.D.

Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
The Rockefeller University
1230 York Ave.
New York, NY 10065
Telephone: 212-327-7280
Email: mlamar@adarc.org
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
With an estimated 33.2 million people in the world infected with the virus, HIV is a major medical problem.

The purpose of this study is to see if HIV-infected subjects currently taking an antiretroviral (ARV) regimen consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus FTC/TDF (Truvada®) can safely switch to EVG/COBI/FTC/TDF STR without increasing the amount of virus in their blood.

The safety and effectiveness of EVG/COBI/FTC/TDF STR will also be compared to an antiretroviral regimen consisting of a NNRTI plus Truvada®.

The safety and how well these drug combinations are tolerated will be determined based on vital signs, physical exams, laboratory tests and questionnaires about your: HIV treatment satisfaction, HIV treatment adherence, general health, anxiety, depression and any problems you might experience during the study.



Detailed Description of Protocol:
If you join the research study, you will take part for a minimum of 100 weeks. The research study as a whole will last about 2 years. If you agree to participate, you will be one of 420 volunteers at approximately 120 study sites in North America, Europe and Australia.

The screening period (the time between the Screening visit and Baseline visit) may last up to 30 days. You will receive the study drug(s) for a minimum of 96 weeks (22 months). You will be required to visit the clinic up to 13 times.

This is an open-label study, which means that you and your study doctor will know whether you are receiving EVG/COBI/FTC/TDF STR or an antiretroviral regimen consisting of a NNRTI plus Truvada®. The randomization for this study is in a 2:1 ratio, which means that your chance of being assigned to Study Treatment Arm 1 is two times greater than your chance of being assigned to Study Treatment Arm 2. You and your study doctor will know which study treatment arm you are assigned to.



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

- Have been on your first anti-HIV drug regimen for at least 6 mos
- Are currently taking Atripla or Complera
- Currently have an undetectable viral load for the at least 6 mos

Gender:
Both

Age(s):
18+

Children permitted to participate:
No

Potential Benefits.....
There is no guarantee that you will receive personal benefit from participating in this study. The study drugs are not expected to cure you of HIV. However, clinical research studies such as this are a way for doctors to determine if a drug is useful in fighting a disease. By participating in this study, you and the Sponsor, Gilead Sciences, Inc., may benefit if the combination pill of EVG/COBI/FTC/TDF STR is safe and effective in treating HIV-1 infection. Your participation in this study may benefit the community, scientists and doctors who work with HIV by providing increased knowledge and information about the treatment of your disease. In addition, during your participation you will have close medical monitoring of your health condition by blood tests and other evaluations during clinic visits.



Compensation:
Compensation is provided for study participation.