test - march 572 newsletter

Study Team Contacts for IRT Issues:

GSKGSK Clinical Support Help Desk +1 (877) 528-7677 GSKClinicalSupportHD@ gsk.com

HCGMiaesha Campbell Lead Program Manager +1 (310) 356-2826 [email protected]

QUESTClient Response Center +1 (800) 877-7004 [email protected]

PHASE FORWARDIRT User Support +1 (877) 487-7457 [email protected]

DoluTegravIr (572) StuDIes

March 2012

DoluTegravIr (572) StuDIesMonthly update

Helpful SuggestionS

Change of plans? Dispensing Study Medication outside regular visits

You have options. When you encounter a situation in which a subject is running out of medication and is unable to come to the Study site, you may ship Study medication directly to the subject after receiving approval from your monitor and the Central Study Team. Situations that may occur include:

Lost supplies

Travel

Incarceration

Make sure your team has a plan in place to address safety issues surrounding shipping of Study medication prior to requesting Central Study Team approval. Stay on top of business or vacation travel by asking subjects if they have any upcoming plans that may require extra supplies.

Not at This address? Take the Surprise out of Subject relocation

Are you sending appointment reminders that never arrive? Tracking subjects who have moved is much harder after the event, whether the move was across town or out of the country. Please remember to ask your subjects if a future move is planned as part of your regular contact update, even if the answer was no the last time you asked.

Your monitor or the Central Study Team can assist when you receive feedback from a subject regarding an upcoming move to a location outside your site area, as subjects may be able to transfer to another Study site in their new area. If there are no Study sites in their relocation area, HCG may be able to provide transportation support if allowed by your local IRB and/or EC and approved in advance by the Central Study Team.

SprINg2 NrTI reminder: plan for Week 96 Now

Please remember to follow up with your subjects to make sure they secure funds for NRTIs (Kivexa/Epzicom and Truvada) after Study completion. NRTIs will not be provided by GSK during the open-label phase of the Study. Please remember to start planning for NRTI provision early so that the appropriate NRTI is available at the time of the Week 96 visit. Please address any questions to the Central Study Team. This is especially important for subjects in the U.S. and Canada.

DTG (572) Studies Monthly Update | March 2012





Dont let the Window Close: remember the +4/-7 Days for SaIlINg Week 48 visits

Be prepared! Check to determine if your subjects are on schedule. Use the Firecrest visit calculator to determine if your subjects are on schedule to complete the Week 48 visit. The Week 48 visit must be performed within a window that is up to 7 days prior or 4 days after 336 days from randomization. Visits outside this window cannot be registered without approval. Subjects in the Double Blind Phase can complete study participation 336 days after randomization if all scheduled visits have been performed.

It Bears repeating: SaIlINg Week 24 Data for regulatory Submission

If subjects can suppress or re-suppress at Week 24, it will make a difference in our analyses. This is not a mandatory requirement. Please bring subjects back in for a repeat test if their HIV-1 RNA levels are between 50 and 400 c/mL.

You can find an alert in the Quest report when the HIV RNA levels are between 50 and 400 c/ml at Week 24.

Please retest within 4 weeks of the Week 24 visit.

IRT QuICk ReferenCe guIde: enTering the DouBle BlinD CoMpletion visitYour IRT Site User Manual provides a step-by-step guide for you to perform the Week 48 Completion Visit using the IRT system (refer to pages 20 & 25). Here is a quick refresher:

pg. 2

Ste

p 1

Enter the Study completion date.

Ste

p 3

After unblinding, choose one of the following. If randomized to 572: Choose continue on GSK Open Label

or not continue on GSK Open Label.

If randomized to RAL: Choose continue Open Label RAL or not continue Open Label RAL.

Ste

p 4

Respond to the final question Is this for the scheduled Week 48 visit? Answer Yes. The IRT will then assign container numbers for the subject.

Ste

p 5

If the information was entered correctly, the IRT completion function will update the status of the patient in the Study.

Ste

p 2

Select unblind treatment.

CongratulationsSAILING sites exceeded the enrollment goal! The Study enrolled 724 subjects, surpassing the enrollment target of 688.

DTG (572) Studies Monthly Update | March 2012





ral BrIDge TReatMenT enTranTSThe Study protocol provides a bridging supply of RAL for up to 4 weeks. Bridge treatment should be offered to subjects only when necessary, for example, to allow for processing of paperwork. Protocol Section 5.8 explains appropriate applications. Please let the Study monitor know in advance if a subject will need RAL bridge supplies.

During the IRT unblinding, respond to the following:

Has this unblinding been discussed with GSK? Please confirm if the Week 48 visit is within the visit window. If so, this is a protocol-allowed unblinding, and therefore no discussion with GSK is required. Answer No.

The IRT system will also ask if you have talked to GSK prior to issuing the additional 4 weeks of bridging RAL. Answer Yes. Note that Raltegravir bridging supplies will not exceed 4 weeks in countries where Raltegravir is commercially available.

StuDy CoMpletion Data in the IRTWeek 48 marks Study completion for RAL subjects, as well as any subjects taking 572 who do not go into OL. Please take the following steps to ensure you avoid recording these subjects as a Withdrawal or Early Termination in either InForm or the IRT.

Register the Study completion in the IRT.

Complete Week 48 dispensing for subjects receiving Open Label 572 or Bridging RAL.

Dispense Week 48 drugs from the Double Blind stock, even though the subject has been unblinded.

Record the containers dispensed at the Week 48 visit on the Double Blind COMP forms.

Use InForm to complete the Week 48 visit DBCONC. This ensures the correct forms for Open Label or Bridging appear.

Start using the Open Label COMP forms at Week 60.

Record all 90 tabs dispensed on the same row as there is no need to capture container numbers starting at Week 60.

atTention: TReatMenT AsSIgNMenT isSues in the IRTThe Study team has identified a problem that may occur during unblinding. The Oracle team is working to resolve this. The Study team will keep you apprised of their progress. Until it is resolved, you may experience the following:

After IRT unblinding, you receive an email confirming the subjects correct treatment assignment (e.g., 572 or RAL). However, it also states Open Label GSK 572 = Yes even if the subject was taking RAL.

You MUST record the original treatment assignment in the subjects source documents if the IRT unblinded treatment of RAL does NOT match the written fax or email confirmation.

Contact the PF Help Desk ([email protected] or at the toll-free numbers listed on the IRT home page) to request a written confirmation as seen below:

pg. 3

There is a known issue with the Completion from Double Blind visit notification, and I can confirm that subject XXXXXX was on Raltegravir.

The Oracle team is working on a fix now. The study team is across the issue and is receiving updates.

test - march 572 newsletter

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