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Author Topic: Clinical Studies...Are they Safe....  (Read 2690 times)

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Offline Kmg1947

  • Member
  • Posts: 43
Clinical Studies...Are they Safe....
« on: December 10, 2015, 10:04:57 am »
Hello Poz Family,

It has been a min. I pray all is well. I just wanted to ask a question that
my son ask me. Are any of you familiar about clinical studies and how they
work with HIV. My son has relocated to Georgia and is in the process of
changing over plans, doctors etc since being in the new state. He heard
from some friends that clinical studies help with medication, and out of
pocket cost on certain meds by trying the med through their study.
Is this a good idea???

Loving Life through the Ups & Downs.

K

Offline Jmarksto

  • Member
  • Posts: 667
Re: Clinical Studies...Are they Safe....
« Reply #1 on: December 11, 2015, 12:09:58 pm »
kmg;  There are a wide range of clinical studies - and in short, the more advanced they are the "safer" they are.  Clinical studies go through three basic phases:


Phase 1: which is generally done on a very small group of people to test the basic safety. The number of subjects are so few, that the biological response may not be statistically significant. They may test different does levels.


Phase 2: with a somewhat larger sample size, but still looking for basic safety and the biological (immunological in this case) response, including dose levels is being monitored and evaluated.


Phase 3: is generally done with several hundred or thousands of people which is done just before the drug is approved by the FDA and goes to market.


Phase 4: (I know I said there were three phases....) is a post market evaluation of the drug


https://en.wikipedia.org/wiki/Phases_of_clinical_research


The knowledge of the drug and its interactions improve with each phase, and as such the "safety" does too.  I would ask a few key questions, which are:


 - what is the phase of the study?
 - how many people have gone through the previous phases?
 - what side effects/interactions/etc. have been reported to date?
 - what are the biggest risks with this drug/study?
 - what study findings/papers/reports/etc. are available for review
 - what kind of tracking/follow up/ongoing care is provided


I hope that helps.



03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45% VL 25
02/25/14 CD4   792/37% VL UD
07/09/14 CD4 1004/39% VL UD
11/03/14 CD4   711/34% VL UD
03/13/15 CD4   833/36% VL UD
04/??/15 Truvada & Tivicay
06/01/15 CD4 1100/50% VL UD
10/16/15 CD4   826/43% VL UD
??/??/2017 Descov & Tivicay
2017 VL UD, CD4 stable around 850
2018 VL UD, CD4 stable around 850

Offline Kmg1947

  • Member
  • Posts: 43
Re: Clinical Studies...Are they Safe....
« Reply #2 on: December 17, 2015, 10:17:26 pm »
Thank you for the insight.

Kmg
Loving Life through the Ups & Downs.

K

Offline emeraldize

  • Member
  • Posts: 3,397
Re: Clinical Studies...Are they Safe....
« Reply #3 on: December 18, 2015, 07:26:11 pm »
To add to Jmarks post-- you are in the U.S. --our HIV-related therapeutic studies have strict NIH-monitored criteria to meet, not only in terms of process, but ensuring appropriate participants are enrolled.

Offline wolfter

  • Member
  • Posts: 5,470
Re: Clinical Studies...Are they Safe....
« Reply #4 on: December 18, 2015, 07:46:23 pm »
The entire point of a clinical study is to to obtain these answers. 
Being honest is not wronging others, continuing the dishonesty is.

Offline GoForIt

  • Member
  • Posts: 214
Re: Clinical Studies...Are they Safe....
« Reply #5 on: December 18, 2015, 08:08:35 pm »
Hello Poz Family,

It has been a min. I pray all is well. I just wanted to ask a question that
my son ask me. Are any of you familiar about clinical studies and how they
work with HIV. My son has relocated to Georgia and is in the process of
changing over plans, doctors etc since being in the new state. He heard
from some friends that clinical studies help with medication, and out of
pocket cost on certain meds by trying the med through their study.
Is this a good idea???

Long as you get the medication you wanted and you are not taking too much risk in the trial.

There are a lot of trials, just need to make sure you are signing up with the right one you are comfortable with. 

Some trials are for certain meds, some for gene therapys, some have higher risks than others.

I myself signed up for the TAF switch from Truvada trial because it was in phase 3 (already tested for safety in efficacy) and just needed the larger group for the last trial before it came to market.  So for 2 years I get free TAF and free labs and dexa scans which would cost a lot if I wasn't on the trial.  Plus I get to be on the latest medication which I like.

08/09/2013  Diagnosed WB positive
08/20/2013  CD4-506(28%)  VL-10,800
09/12/2013  CD4-391(28%)  VL-14,900
09/17/2013  Start ART (Truvada + Tivicay)
10/11/2013  CD4-377(26%)  VL-UD
12/20/2013  CD4-590(??%)  VL-UD
03/18/2014  CD4-660(29%)  VL-UD
07/22/2014  CD4-613(29%)  VL-UD
08/01/2014   Start Phase 3 TAF (Truvada 2.0) Clinical Trial (TAF + Tivicay)
10/09/2014  CD4-498(29.5%) VL-UD
11/06/2014  CD4-600(30.2%) VL-UD
01/30/2015  CD4-529(31.3%) VL-UD
07/25/2015  CD4-742(36.5%) VL-UD
10/06/2015  CD4-765(28.9%) VL-UD
01/05/2016  CD4-907(33.1%) VL-UD
03/24/2016  CD4-770(33.5%) VL-UD
06/20/2016  CD4-850(35.4%) VL-UD

Dr. Mark Wainberg on Dolutegravir:
Video 1: https://youtu.be/wCXOgLJqJAY
Video 2: https://youtu.be/DKiaD7fHO-s

 


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