Gilead study GS-US-248-0131 - phase 2 all oral

[OC]

I was screened today for the Gilead Protocol Number: GS-US-248-0131, Clinical Trials Identifier: NCT01435226

http://www.clinicaltrials.gov/ct2/show/NCT01435226?term=gilead&state1=NA%3AUS%3ACA&rank=13

“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-
Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection”

This study also has a sub study (rescue therapy) that involves:

If the study doctor determines that you are not responding to the study drugs, you will be offered additional medications to treat HCV. If you decide to participate and receive the rescue therapy, you will receive GS-5885, GS-9451, PEG and RBV for up to 24 weeks, followed by up to 24 weeks with just PEG and RBV depending on your response to study drugs.

I will know shortly if I will be participating in this study.

What are your thoughts on this trial since this is a randomized, double blind, placebo-controlled study?

peace

[jsf52]

Glad that the trial coordinator connected with you.  You are almost there.  Keep drinking lots of water.  Keeping you in prayers.  Best, Jeff

[OC]

got a call from the study coordinator yesterday:

they're dropping the PEG to 135mcg because my absolute neutrophils are at .68, if I go down to .50 i'm off the PEG...Riba still at 800

HGB 10.6
Platelets 67

107 more days to go

peace

[nowhine]

OC...also please keep us posted. Thanks.

[nowhine]

OC- glad to hear you are still in the battle, keep up the fight. I believe the PCR test are correct for this trial. I don't have my info. with me but I will look at it when I get home and let you know if different. I know that the trail protocol is to reduce the riba if HGB goes below 10. If your HGB is "slightly above 10" I know you don't feel that great. Just praying that some comfortable days are ahead. Stay in the fight.

[orphanedhawk]

I just did 24 weeks of SOC with viral loads at 4, 12 and 24 weeks.  But I think 24, 36 and 48 sounds right.
I think if you do a separate post about your situation you might get more replies.
Hang in there~

[jsf52]

Glad that you are still slaying the dragon.  Try and get some rest - what did the trial team say about the HGB and platelets?  Hope that you have a good 4th.  God bless.