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(MMA-0705) A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of EVG/FTC/TDF/GS-9350 Vs Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults


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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:
Saurabh Mehandru M.D.
Teresa Evering M.D.
Marina Caskey M.D.

Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
The Rockefeller University
1230 York Avenue
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 reason for doing this research is to see if EVG/FTC/TDF/GS-9350 is safe and effective in reducing levels of HIV-1 in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication). You have been asked to participate in this study because you have HIV and you are treatment-naïve. If you have previously (ever) taken, or are currently taking any antiretroviral medication (medications that fight retroviruses like HIV or hepatitis), you will not be allowed in the study.

The safety and effectiveness of EVG/FTC/TDF/GS-9350 will be compared with that of Atripla®. Atripla® is a combination medication containing efavirenz (also known as Sustiva®), FTC and TDF. Atripla® has been approved by the FDA for the treatment of HIV. An approved dose of Atripla® is being used in this study. The safety and how well these drug combinations are tolerated will be determined based on physical exams, laboratory tests and questions about any problems you might experience during the study. As part of this study, levels of HIV-1 in the blood and drug levels of GS-9350 and EVG (and possibly FTC and TDF) will be measured at various times during the study.

This research study is sponsored by a drug company. The name of the Sponsor is Gilead Sciences, Inc.



Detailed Description of Protocol:
The screening period (the time between the Screening visit and Baseline visit) may last up to 35 days. The screening period may be extended to up to 42 days after the Screening Visit if a certain screening test called a genotype needs to be repeated. You will be treated with the study drug(s) for a minimum of 96 weeks (22 months). During this time, you will be required to visit the clinic at least 15 times. Following your 96 weeks on-study, you will continue to take your study drugs and attend visits every 12 weeks thereafter until the study is unblinded (“unblinded” means that you and your study doctor will be told which treatment arm you received). Subjects who complete the required on-study treatment and who qualify will be offered the opportunity to receive EVG/FTC/TDF/GS-9350 as part of a separate, open-label roll-over study. “Open-label” means you and your doctor will know what study drugs you will be taking.

Subjects who choose to participate in the open-label rollover study will receive EVG/FTC/TDF/GS-9350 until it becomes commercially available or until Gilead Sciences chooses to stop the development of the EVG/FTC/TDF/GS-9350 fixed-dose combination tablet.



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

If you:
- Have no prior use of HIV medication
- Have a viral load of >5,000 copies/mL


Gender:
Both

Age(s):
18 and older

Children permitted to participate:
No

Potential Benefits.....
The study drugs are not expected to cure you of HIV-1 infection. However, information gained from your participation in this sub-study may help to determine if EVG/FTC/TDF/GS-9350 is effective in treating HIV-1 infection and is safe and easy to tolerate. Your participation in this sub-study may benefit the community and scientists and doctors who work with HIV-1 by providing increased knowledge and information about the treatment of your disease. Gilead Sciences, Inc. may also wish to use the information collected about you during the sub-study and your biological samples in future research for the treatment, prevention or diagnosis of HIV-1.

In addition, during your participation you will have close medical monitoring of your health condition by blood tests and other evaluations during study site visits.



Compensation:
Compensation will be provided.