A Simplification Study of Unboosted Reyataz with Epzicom | May 2012

Subject Travel TipsThe travel season in upon us! Whether the destination is across town or across country, traveling HIV positive requires additional preparation and precaution. Providing subjects with guidelines on how to stay on schedule with medications is a good start, but a few simple watchwords can prevent compliance disasters.

Packing BagsIt’s good common sense to make sure medications are always accessible when traveling.

Pack pills firstRemind subjects to pack their pills first. It’s not a big deal to forget a toothbrush, but subjects can’t replace study medication at the airport gift shop.

Carry medication in the Study packagingTell subjects that weekly pillboxes help manage medications, but can cause hassles and delays with security and customs.

Put pills in a carry-on bagEnsure subjects keep study medications with them at all times. Flights get delayed; checked baggage can get misrouted.

Bring waterRemind subjects that dehydration affects all passengers on longer flights and HIV positive people may be more susceptible.

Simplify dosing issuesInstruct subjects when to take medications when crossing time zones.

Crossing BordersIf you discover that a subject is traveling abroad, ask questions to help avoid unintentional compliance issues.

Inquire about any known HIV positive travel issues. Some countries still have restrictions regarding HIV positive visitors. A letter from your practice describing the subject’s HIV status, study participation and medications may be useful in an emergency.

Research CDC country-specific information. Caution subjects that recommended vaccines and precautionary antibiotics should be discussed with your office first, as some may be contraindicated. Contact the study team if you have questions.

Counsel about food safety. Help subjects avoid food-borne illness:• Drinkonlybottled,filteredorboiledwater.Declinebeverageswithice• Avoidrawvegetablesandfruitsthatcannotbepeeled• Takeextracautioneatingdairyproductsandanyfoodofferedbystreetvendors

What if… If your subject reports not having access to medication: whether it is lost, misplaced or he/she is running out and unable to come to the site for replacement, call the study team. We will evaluate situations on a case-by-case basis and may be able to help you resolve the crisis.

Contacts:

Melinda Bomar GSK Operations & Science Lead (919) 483-7904 melinda.m.bomar@gsk.com

Daphne Percival GSK Clinical Study Associate (919) 483-6136 daphne.c.percival@gsk.com

Nicole Swart HCG Project Manager (310) 356-4809 nswart@hcg.com

Cindy Durkin CogState Senior Clinical Project Manager (203) 773-5010 cdurkin@cogstate.com

Rod Elizondo Project Manager Clinical Trials (661) 964-6510 rod.x.elizondo@ questdiagnostics.com

Lisa RossGSK Clinical Investigational Lead(919) cin483-6325lisa.l.ross@gsk.com

David MargolisGSK Physician Project Lead(919) 483-7869david.a.margolis@gsk.com

A Simplification Study of Unboosted Reyataz with Epzicom | May 2012 A Simplification Study of Unboosted Reyataz with Epzicom | May 2012

Retention Star: North Texas Infectious Disease Consultants 8 Screens 6 Randomizations 100% compliance

One subject traveled 356 miles round trip to complete visits at the NorthTexasInfectiousDiseaseConsultantsstudysite.Why?Theextra care and support he received throughout his participation in the study. With the last enrolled patient approaching his 48 week visit,isitanysurprisethattheresearchteamatDr.Sloan’ssiteinDallas,TXhasachieved100%complianceforASSURE?Theteamattributes their success to personal attention and inspiring subjects to commit to caring for their health.

Study Coordinator Shelby and Research Manager Bryan, place a premium on prompt response to questions, and immediate access to the Investigator when the need arises. The practice uses Primary Care Physicians as sub-Investigators, so study subjects are patients with longstanding relationships with their physician. The practice’s structure may be unique, but anyone can adopt their relationship-building attitude. “We work together as a team to communicate and maintain rapport with patients,” states Bryan.

“I call every subject between visits,” says Shelby. “Subjects appreciate the attention.” Confirming an appointment is the ideal point to check in and make sure subjects are clear about dosing and other expectations. Jessica, the site’s Research Assistant, makes reminder calls the day before the visit. Shelby also confirms and updates contact information after each visit.

Supporting the HIV community-at-large is also a part of the site’s mission.WithconnectionstoAIDSResourceofDallas,thesitecanoffer subjects vital links to support resources.

Kick-Off Summer in Style: Study Coordinators’ TeleconferenceThe next Study Coordinators’ Teleconference is scheduled for the weekofJune18th!Signupforoneoftwotimeslots.Sessionswillbe held on:

18 June 2012 at 10:00am PT/1:00pm ET 20 June 2012 at 12:00pm PT/3:00pm ETPlease ensure at least one member of your study team is available to attend, as the agenda will include pertinent study information. Tojointheaudioconference,dial1-888-643-3083andenter34988734#.

Early Intervention Makes the DifferenceLife changes affect subjects’ motivation and often their ability to continue study participation. Early intervention can make the difference betweenLostToFollow-up(LTFU)andcompletion.Ifasubjectmissesappointments, constantly reschedules or comes late, he/she is already displaying pre-withdrawal behavior.

Speak with subjects at each visit. Ask open-ended, non-leading questions about how their life is going. This shows concern and will also help you understand any changes in behavior that you are seeing. If a subject is truly at-risk, you can work together to devise a specific plan to overcome issues. A wavering patient may just need a little extra care to get back on track.

CISCRP Membership: Where Will it Lead?Weheardyou!DuringthelastStudyCoordinators’Teleconference,youexpressed interest in receiving a CISCRP membership. Please keep a look out for the membership in the mail.

Whatcanyouexpectwiththismembership?AccesstotheonlineCISCRP portal provides a wealth of patient resources:

• Materials that will help explain different aspects of clinical trials to subjects and potential subjects come IRB approved in multiple languages through your CISCRP membership

• MedicalHerotruestories that will inspire and remind subjects about the real meaning of participation are available for download anytime on demand. Reprints will be provided for distribution

• Patientcommunityresources placed at your fingertips through the CISCRP Online Support Community allow you to provide a new level of personal attention for subjects

• Factsandfigures about research will enrich presentations and discussions with patients

Check your Inventory for Expired LotsThe following study medications recently expired. Please be on the lookout for the following lots:

• Atazanavir200mgexpires3/31/2012;commerciallot0C5024A

• Atazanavir200mgexpires3/31/2012;commerciallot0C5020A

• Epzicom600/300mgexpires3/31/2012;commerciallotR411399

• Ritonavir100mgexpires4/8/2012;commerciallot903682E21

A Simplification Study of Unboosted Reyataz with Epzicom | May 2012 A Simplification Study of Unboosted Reyataz with Epzicom | May 2012

Five Easy Steps for a Successful Week 48 Visit:1. ScheduleWeek48visitsattheWeek24orWeek36visit,targetingthebeginingofthewindow

2. Call the subject in between visits. Life changes happen over a 3-month period, so please make sure to check-in

3. Remindsubjectsofcomplianceitemsandstipendsavailableatupcomingvisits(ifIRBapproved)

4. Contact the subject one day prior to the scheduled visit using the subject’s preferred method. Make sure you receive confirmation back from him/her

5. Enlist the help of the PI when repeated attempts to reach the subject fail

Mark the Date for 48Week 48 visit window is important. The data is necessary for successful ASSUREcompletion.Schedulingpatients as early in their visit window as possible will allow for any appointment hiccups. To the left is a graph detailing when all remaining subjects are due for Week 48 visits.

Make a Lasting Impression“No one thanked me.” This is one of the most common comments made by study participants when surveyed upon completion. As patients approach their Week 48 visit, we have a solution. Amid everyday texts and emails, a mailed card turns a simple sentiment into a lasting reminder of participation. Thank You Cards are available through HCG. Please contact Nicole Swart at 310.356.4809atHCGifyoursuppliesarerunninglow.

Departingparticipantsalsooftenask:“Whathappenedwiththestudy?”Make sure the subjects are directed to the right place to find study results. HCG can supply you with IRB approved Insert Cards to include with your Thank You.

Have you had an ASSURE patient experience a viral load increase above 50 copies/mL and/or a therapy interruption or counseled a non-compliant patient?Scenario(s):Yourpatienthadalateout-of-officevisitwhichresultedinbeingofftherapy(duetorunningoutofstudymedication)OR your patient returned study drug OR admitted a therapy interruption OR you suspected non-compliance and counseled your patient on the importance of taking their study medication.

Action: Please note this information in INFORM. Please specify the subject, the specific issue/circumstances, along with the study visit and suspected duration off medication. If the subject’s current or subsequent viral load result is elevated, your comments are VERY important to help explain what could have contributed to the rise in viral load.

A Simplification Study of Unboosted Reyataz with Epzicom | May 2012 A Simplification Study of Unboosted Reyataz with Epzicom | May 2012

HaginsSmall

MelendezBrennan

Clay ClayBrennan

SantiagoHIV Vaccine Awareness Day

National Asian & Pacific Islander HIV/AIDS Awareness Day

Brennan

ByJuly,allsubjectswillhavecompletedtheWeek24visit.Checkthecalendarbelowto see if your site has subjects with study visit windows beginning in May. Mark these dates to ensure the visits are scheduled. This data is crucial for submission to ICAAC, sopleasehelpthestudybycompletingtheWeek24visiton-timeandwithinwindow.

International AIDS Conference 2012: World AIDS 2012 ASSURE Study PresentationPrevalence of HIV Associated Neurocognitive Disorders (HAND) in Virologically Suppressed HIV positive Individuals will be presented on 25July2012attheInternationalAIDSConference.Congratulationstotheco-authors,Drs.Wohl,Bhatti,EdelsteinandSmall.Whatisincludedintheabstract?TheresearcherscomparedthebaselineCogstateresultsfromourASSUREsubjectswithnon-HIVinfectedsubjectsandsawasubstantialincreaseincognitiveimpairmentinASSUREsubjectscomparedwithnon-HIV-infectedsubjects.Theolderthesubject(whetherHIV-infectedornot),themorelikelytosee decreased cognition.

For those not attending, the poster will be uploaded to our team site after the meeting.Thefullpresentation(plusmeetingfeedback)willbemadeavailablesometimeaftertheconferencepresentation.Detailstofollow.

Call to action! In order to finalize the data in time for the week 24 analysis, please try to address queries as soon as possible to avoid a delay!

May18thisHIVVaccineAwarenessDay

(HVAD).Thisannualobservancerecognizes

and thanks the thousands of volunteers,

community members, health professionals

and scientists who are working together to

findasafeandeffectiveHIVvaccine.(NIH)