Considering participating in a clinical trial for "MK-1439..."

[survivor703]

Hello everyone,

I know I've been out of the loop for a while. My apologies about that.

Today, I saw a new specialist (insurance changed on the job). I haven't started meds yet, but I believe this is the month where I'm going to start. They're running a 2-yr clinical trial here in my hospital for a drug from Mark called MK-1439. It's either that or get started with Atripla. I'm not really sure what's the best option. Money isn't an issue, but it seems like the only advantage (to me) is to get free meds. Just trying to weigh the risk vs the benefit. What do you guys think?

Thanks,
Survivor!

[Jeff G]

Welcome back ! .

My first concern when anyone is starting meds and its Atripla that is chosen is to ask whether you have any ongoing or prior mental health issues or even mild depression you have or have had in the past . If the answer is yes then I would not recommend Atripla .

I am not familiar with the study you mention .

 

[eric48]

Nct01632345 ?
If so randomized; 50% get the new drug 50  % get Atripla
The molecule is huge! So should be Well tolerated...
Mobile.eric

[J.R.E.]

Hey Survivor,..

Good luck with whatever decision you make.  It's entirely up to you and your Doctor at this point if you want to participate. But either way it looks as though you will be starting meds shortly. 

I am assuming that this is Phase 2 of this trial ? Whatever you decision we will support you.


Here is a brief lesson from this site, that may help you make up your mind on this : Make sure to check out the Poz cast as well as reading all pages of this lesson.

http://www.aidsmeds.com/articles/clinical_trials_21176.shtml


Joining a Clinical Trial :

http://www.clinicaltrials.gov/ct2/show/NCT01632345



Pretty much everything we know about how HIV treatment depends on research—and not just any research, but clinical trials involving HIV-positive people. Today’s men, women and children living with HIV have yesterday’s clinical trial volunteers to thank for the highly effective, better tolerated and easier-to-take medications now available. Similarly, the future of our ability to respond to the needs of people living with HIV—whether its novel drugs for those starting therapy for the first time or in desperate need of new agents, new approaches to managing side effects or, best of all, a cure for the disease—depends greatly on people to continue enrolling in clinical trials today.

Of course, deciding to participate in a clinical trial isn’t only about altruism—putting the needs of others before our own. Though most people living with HIV today have an abundance of treatment options to choose from and do not need clinical trials to access life-saving therapy, this is not true for everybody. A growing number of people are at the end of their treatment rope, given that their HIV has developed resistance to most, if not all, of the approved meds. There are also individuals who cannot tolerate many available treatments and need access to alternative options or experimental drugs for side effects. And there is always interest in trying new compounds that are easier to take, work differently than any agents approved to date or are potentially effective against non-AIDS diseases that affect people living with HIV, such as cancers, hepatitis, mental health problems and heart disease.

Should you join a clinical trial? Like all treatment decisions, this question can only be answered through discussions with your health care provider and others you trust.  To help you better understand clinical trials and to have these discussions, we offer the following detailed lesson on the subject.

What Is A Clinical Trial (or Study)?

A clinical trial is a medical experiment that takes place in a hospital, a clinic or a doctor’s office. The experiment may test the safety and usefulness of a new drug, or it may test several different kinds of drugs or treatment strategies to see which one is better. Some clinical trials test drugs that treat HIV directly, while other trials test drugs that treat or prevent the opportunistic diseases and non-AIDS-related complications that commonly affect people with HIV. Studies may also test easier or more effective ways to take medications, or strategies to treat side effects of medications.

There are also trials under way contributing to research surrounding a cure for HIV/AIDS.

The first trials of a new drug performed in humans are known as Phase I studies and test the safety of the treatment. These studies may also look for early signs of effectiveness, such as viral load reductions after the drug is taken for one or two weeks.

Once Phase I studies are completed, the drug moves into Phase II testing. These studies collect safety and dosing information and begin to see how effective the treatment is when taken for several months.

Phase III studies are larger, longer trials designed to confirm whether or not a treatment works and whether there are important safety issues.

The U.S. Food and Drug Administration (FDA) will review data from all of the trials, along with test tube and animal studies, to determine whether or not to approve the drug. Sometimes, an important new drug is granted “accelerated approval” by the FDA while the Phase III studies are still ongoing. Other times, the FDA requires all studies to be completed before an application for approval can be filed.

Finally, Phase IV studies may evaluate the approved drug in more people and different populations. Phase IV studies, also known as post-marketing studies, are also conducted to test several different approved treatments, to find out if one works better than others.

Unfortunately, some people living with HIV enter clinical trials to gain access to a doctor or clinic because they may not have any other options for receiving care. Some trials provide the equivalent of free care and medication, but some do require that approved meds be provided by the participant. Although participating in a study may be a useful part of your treatment, it is important to know that the main purpose of the trial is to test the treatment—not to provide the best possible medical care. Therefore, study participation is not a good substitute for regular doctor visits.

Most, though not all, clinical trials compare at least two different drugs or drug regimens. For example, a study might compare a new antiretroviral (ARV) in combination with older ARVs in one arm (or group) to a combination containing only older (but effective) ARVs in the second arm or group. When an experimental or new treatment is compared to already approved standard treatments, the second arm is known as the control group.

Another type of control used in clinical trials is known as a placebo—a fake, sugar or dummy pill—that contains no medicine but looks exactly like the tested treatment. Today, HIV clinical trials rarely use control arms in which only a placebo is given. This is because we already have effective treatments—an experimental drug or regimen needs to show that it works better, causes fewer side effects or is easier to take than drugs or regimens that are already available.

When studies compare different medicines, a computer may used to randomly assign you to one of the treatment arms. This is known as randomization. This is important, as it prevents the researchers conducting the study from being biased—for example, assigning patients they already have a relationship with to receive the experimental treatment and those they don't know to receive a placebo. 

Additionally, you may not be told which treatment you are receiving. This is known as a blinded study because the participants don’t not know whether they are in the control arm or in the arm receiving the studied treatment. When both the study participants and the doctors don’t know who is in the control group, the study is called double-blind, again to prevent clinical trial staff members from being biased.

The government usually tries to carefully regulate clinical trials. The information in this AIDSmeds lesson is specific to the United States. However, most developed countries offer similar regulations for clinical trials.


This continue on.....

[survivor703]

thanks everyone for the input... And a special thanks to J.R.E. for the detailed answer and supporting documents. This makes my decision a lot easier. I'm going to go ahead and participate.

Thanks

[J.R.E.]

Hey Survivor,.!

Wishing you the very best, and good luck with your decision to enroll in this study.

You will have to keep us updated, as you go through the process, we will be looking forward to the updates. Don't forget to ask questions. This will be a good time to write those questions down, so you will be prepared.

For the record, When I spoke to my ID doctor in December, I re-reminded him that I wouldn't mind enrolling in a clinical trial, if one came up and he seemed alright with it, and I met the requirements.

I have only been in one previous clinical study, and that was at least 6 years ago or longer.  This was not for HIV medications, but was the Capsaicin ( Patch) study.  I believe that study lasted 6 weeks or so, and if I had to do it again, I would do it.


Good luck to you, keep us informed----


Ray