Will my information be kept private?
Personal and medical information about you will be kept private and all discussions with study staff will be discreet. Study information will be kept in secured files. Any communication you receive from the study staff will refer to the study name, Spring-1, not the type of study or what disease is being treated. If you pre-qualify based on a telephone interview or the online questionnaire, the study site staff can answer further questions you may have about the privacy and security of your information.
What is the purpose of this clinical research study?
This study will look at how people react to GSK1349572 and if it reduces the amount of HIV in the blood at different doses.
Who qualifies for these studies?
In order to participate in a clinical research study, you must first provide informed consent. Next, you will be evaluated for basic entry criteria. The basic entry criteria to qualify are: Men or women 18 years of age or older, living with HIV, who have not started anti-HIV treatment. Click on “How Do I Qualify” to see if you or someone you know may qualify.
What does giving “consent” or “informed consent” mean?
Giving your consent means that you have the right to freely decide if you will take part in a research study. Giving your informed consent means you are well informed or told about the study and have any questions answered before giving consent. As one of the beginning steps in joining the study, you must read and sign a form called the Informed Consent Form which gives in writing all the details important to you about the study and records your decision to join.
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You should give your consent to join the study only after:
A study staff person has explained the research study to you
You know the purpose of the study and the risks, and
You are willing to do what is asked of you in the study
Talk with your family, friends, and your study doctor to help you make your decision. You can take as much time as you like.
You may change your mind at any time during the study. You may leave the study at any time, even if you have signed the Informed Consent Form. You do not have to give a reason.
In talking over the study with you, the study staff person will be able to answer your questions such as:
What side effects or risks can I expect from this study?
Why is this study being done?
Will I receive payment for being part of this study?
Will I have to pay anything to be part of this study?
What anti-HIV drugs will I take in this research study?
On this study, you will receive either an investigational drug in the class called HIV integrase inhibitors or an FDA approved anti-HIV drug called efavirenz (Sustiva®). These will be combined with two additional FDA approved anti-HIV drugs in the class called nucleoside reverse transcriptase inhibitors (NRTI).
If you receive the investigational drug, you will take one of 3 different strengths or doses.
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This study will compare different doses of GSK1349572 which is an investigational drug in the class called HIV integrase inhibitors. Integrase inhibitors block one of the three enzymes (chemical in the body) used by the body to make more HIV. These enzymes are called reverse transcriptase, protease, and integrase.
Three groups of people will take different doses of GSK1349572 and another group will take Sustiva® (efavirenz). You will also be taking another FDA approved HIV medication [either Truvada® (tenofovir DF/emtricitabine) or Epzicom® (abacavir/lamivudine)) that has been chosen by you and your study doctor.
You and your study doctor won’t know which dose of GSK1349572 you are receiving. You will receive GSK1349572 and possibly one placebo tablet (“sugar pill”). This way, the findings from the GSK1349572 groups and the Sustiva® (efavirenz) group will be handled in the same way.
Where are the research sites? There are study sites located throughout the US and in France, Spain, Italy, Germany and Russia.
How many people will be in this study? About 200 people will take part in this study. Once we have about 200 people who agree to be in the study, we will not invite any more people to participate.
How long will the trial last? Your participation in the study will be 96 weeks (almost 2 years) or longer, and will have about 17 or more office-visits to the study doctor. Each office visit will last about 1 ½ hours. Some visits may be longer or shorter.
How can I get help with transportation or child / adult care? Payment may be available to assist with the reimbursement of travel or child/adult care expenses. The research site may be able to provide assistance with locating the nearest public transportation service or child/adult care center.
Should I still see my own doctor? You are encouraged to discuss your participation in this research study with any doctor you may be currently seeing. The research study doctor will normally be able to keep your current doctor informed of your progress and any test results.
Who is sponsoring the study? The study sponsor is GlaxoSmithKline.
Are other HIV studies available if I do not qualify? Ask your doctor about any HIV studies available in your area. Also, the Internet web sites www.clinicaltrials.gov and www.centerwatch.com provide a list of clinical trials that may be useful to you.
Privacy Policy
Please be advised that if you contact us you may be asked to provide personal information including e.g. name, age, gender, geographic location, phone number and email address.
We take all reasonable precautions to keep any personal information you provide private and secure. Your information will not be sold to outside companies, nor will it be stored or collected without your direct consent. For a detailed Privacy Policy Statement click the “Privacy Policy” button on the website www.inclinix.com.
