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(MMA-0728) A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy


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A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects (GSK ING114467)

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
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:
The reason for doing this research is to find out if an investigational drug called GSK1349572 can help people with HIV.
The purpose of this study is to test the safety of GSK1349572 and how well it works. GSK1349572 given along with Epzicom (a combination of two HIV medicines-abacavir and lamivudine) compared to Atripla (a combination of three HIV medicines- tenofovir, emtricitibine, and efavirenz), which is used to treat HIV infection. Participants will get GSK1349572 plus Epzicom or Atripla. GSK1349572 is not approved for doctors to prescribe to patients.



Detailed Description of Protocol:
About 788 adults in 15 countries will take part in this study. Approximately eight volunteers will be enrolled at the Rockefeller University Hospital. Study participation lasts approximately 2 years.

In this study you will receive an experimental drug called GSK1349572. The United States Food and Drug Administration (FDA) has not approved this drug for general use by the public. However, we have told the FDA about this study, and it has allowed this drug to be used in this study.

This study will compare GSK1349572 plus Epzicom to Atripla. One group of people will take GSK1349572 and a combination pill called Epzicom and another group will take Atripla. The effects of the drugs, both good and bad, will be compared. Information about how the study drug you get affects your body and your health will be collected through a number of tests and procedures.

If you decide to join this study, a computer will put you into one of two groups by chance. One group will get the drug we want to test (GSK1349572) plus Epzicom plus Atripla placebo tablets. The other group will get Atripla plus GSK1349572 placebo tablets plus Epzicom placebo tablets. A placebo is a tablet that looks like a drug but has no active ingredient. This way, the findings from both the groups will be handled in the same way.



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

- HIV positive
- Have taken less than 10 days of medicine to treat your HIV

Gender:
Both

Age(s):
18+

Children permitted to participate:
No

Potential Benefits.....
Taking part in this study may or may not make your health/condition better. You may find out during the research study that the study drug is helpful to you. Information from this study will help doctors learn more about HIV and treatment for HIV. This information may help future HIV patients.



Compensation:
There is no compensation for participation.