National Institute of Allergy & Infectious Diseases, NIH, DHHS

DAIDS Multinational Data and Safety Monitoring Board

Clinical Trials Review Meeting

May 14-15, 2015

Logistical Fact Sheet for PROTOCOL STUDY TEAMS

Meeting Location: Department of Health and Human Services

National Institutes of Health

Room LD30A&B / Break-out Room LD40

5601 Fishers Lane

Bethesda, MD 20892

Telephone: 240.292.4803

Fax: 240.627.3467

Security Requirements: Please allow time for security screening when entering the building. A photo identification is required and all personal effects will be screened. Visitors will receive an ID badge that will allow access to the lower ground and lobby levels ONLY and must be visible at all times.

Tentative Agenda: THURSDAY, MAY 14, 2015

9:00 a.m.-9:15 a.m. EDT Administrative Session: (Closed)

9:15 a.m.-11:15 a.m. EDT 1077BF/FF/P1084s (PROMISE)

11:15 a.m.-11:30 a.m. EDT BREAK

11:30 a.m.-12:00 p.m. EDT 1077 HEPATITIS B / HBV SUBSTUDY (PROMISE)

12:00 p.m.-1:00 p.m. EDT LUNCH

1:00 p.m.-2:00 p.m. EDT 1077BF/FF/P1084s (PROMISE)

2:00 p.m.-3:00 p.m. EDT impAACT P1081: Update

3:00 p.m.-3:30 p.m. EDT Administrative Session (Closed): Adjourn

FRIDAY, MAY 15, 2015

9:00 a.m.-9:15 a.m. EDT Administrative Session: (closed)

9:15 a.m.-11:15 a.m. EDT INSIGHT 001/START

11:15 a.m.-11:30 a.m. EDT Administrative Session (Closed): Adjourn/Wrap-up

Immigration

Information: Travel to Washington, DC may require you to have a valid passport and, depending upon nationality, a visa may be required for entry. You are responsible for obtaining and completing the required application and for the submission of appropriate documents and fees to obtain a visa from a United States Embassy in your respective country. Please visit the following link for additional information http://usembassy.state.gov/.

Hotel Information: Hilton Washington DC/Rockville Hotel & Executive Meeting Center

1750 Rockville Pike

Rockville, MD 20852
Telephone: 301.468.1100
Fax: 301.468.0308

http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html

You will be responsible for making your lodging reservation at the Hilton Washington DC/Rockville Hotel. Reservations are accepted based on space and rate availability and a credit card is required to make your reservation. You will also be responsible for the guarantee and payment of incidental expenses, such as telephone calls and Internet access. The hotel accepts all major credit cards. Check-in time is at 4:00 p.m. and check-out time is at 12:00 noon.

Please note individual sleeping room reservations must be cancelled 24 hours prior to the check-in time. Otherwise, a no-show fee equivalent to one night's room and tax expenses will be charged to your credit card.

Additional area hotels you may contact in the event the Hilton Washington DC/Rockville Hotel is fully booked.

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
P: 301.822.9200
F: 301.822.9201
http://www.marriott.com/hotels/travel/wasbn-bethesda-north-marriott-hotel-and-conference-center/ / Pooks Hill Marriott
5151 Pooks Hill Road
Bethesda, MD 20814
P: 301.897.9400
F: 301.897.0192 http://www.bethesdamarriott.com / Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
P: 301.897.5600
F: 301.530.1427
http://marriott.com/property/propertypage/wassb

Meals: Because of the Executive Order to “Promote Efficient Spending”, federal and contract employees are forbidden to be involved in the provision or facilitation of food and/or light refreshments for meeting attendees. Therefore, we sincerely apologize we will not be able to provide any refreshments for you during this meeting or take pre-ordered food requests to provide during a working lunch session. For your convenience, there are several cafés and restaurants located inside the building that offers sandwiches, salads, beverages and other food items.

Ground Transportation

in Bethesda, MD: You are responsible for arranging your ground transportation to the Multinational DSMB meeting from the airport or train station. The Ronald Reagan Washington National Airport serves the Washington, DC area and is approximately a 30-minute drive to the Hilton Washington DC/Rockville Hotel and an additional 5 minutes to Fishers Lane.

Please visit the following link for additional information: http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html

From Ronald Reagan Washington National Airport, you may reach the Hilton Washington DC/Rockville Hotel and Fishers Lane the following ways:

By Taxi: Follow the ground transportation signs to exit the airport. Taxis are located just outside the baggage claim area. The cost is approximately $50-$70 one-way to the Hilton Washington DC/Rockville Hotel or Fishers Lane.

§  By Super Shuttle: Super Shuttle Service vans and town cars are available by following the ground transportation signs to exit the airport just outside of the baggage claim area. You may contact them at 1.800.258.3826 or make a reservation on-line www.supershuttle.com. The rate is approximately $29.00 each way to the hotel and there is a cost of $10.00 for each additional person. No reservations are required for pickup from the airport; however, any transport requests from the hotel back to either airport must be made at least 24 hours in advance.

§  By Metro: Metrorail fare cards are available for purchase at machines located at all

Metrorail station entrances. Please visit the following link for additional metro information: http://www.wmata.com/rail/maps/map.cfm.

The Washington, DC Metrorail system has an elevated Metrorail station connected to the concourse level of terminals B and C at Ronald Reagan Washington National Airport. The station is accessible via elevators. Take the Yellow line towards Fort Totten to the Gallery Place/ Chinatown Metro Station. Then take the Red line toward Shady Grove to the Twinbrook Metro Station. The hotel is located across the West parking lot at the Twinbrook Metro Station. Please visit the following link for additional metro information http://www.wmata.com/rail/.

Fishers Lane is approximately 0.56 miles or a 13-minute walk from the Twinbrook Metro Station. Exit the station and walk southeast on Chapman, turn left onto walkway (Parklawn Dr). Proceed east and turn left onto Twinbrook Pkwy. Turn right onto Fishers Lane and the building will be at the end of the block on the left.

§  Bendey Transportation: Reservations are required at least one day prior to arrival. Follow the ground transportation signs to exit the airport. Bendey Transportation serves all three Washington, DC area airports. You may contact Bendey Transportation at 240.413.2293. The rate is approximately $55 per person each way from the Ronald Reagan Washington National Airport, $65 from Dulles International Airport and $85 from Baltimore Washington International Airport.

§  By Car: To reach the Hilton Washington DC/Rockville Hotel from Ronald Reagan Washington National Airport, take the George Washington Parkway North 12 miles to the Capital Beltway (I-495, North) toward Maryland. Proceed approximately five miles and keep left to take the I-270 spur North via exit 38 toward Rockville/Frederick. Take exit 4A to Montrose Road. Montrose Road turns into Montrose Parkway. Continue on Montrose Parkway for 1.5 miles. Turn left onto MD-355 N/Rockville Pike. Continue on MD-355 N/Rockville Pick for 0.7 miles and the Hotel will be on the right.

§  From the Hotel to Fishers Lane via Bendey Transportation Shuttle: The Hilton Washington DC/Rockville Hotel does not provide shuttle service to the Fishers Lane building. As a result, we have contracted Bendey Transportation to provide prepaid roundtrip shuttle service for DSMB meeting participants from the Hilton Washington DC/Rockville Hotel to the Fishers Lane building. Bendey Transportation will not be making multiple trips after his departure from the pick-up site. Therefore, please ensure you board the shuttle in a timely manner at 8:00AM in the morning and following the meeting. Otherwise, please make alternate arrangements for your roundtrip transportation to and from the meeting from the hotel.

Climate: The weather in Washington, DC in May will be cool, with the average temperature ranging from 74° Fahrenheit or 23° Celsius during the day, to 56° Fahrenheit or 13° Celsius during the evening; however, the hotel is climate controlled.

Parking: The Hilton Washington DC/Rockville Hotel offers parking at a daily rate of $15 per day. Public parking is located at 5635 Fishers Lane, approximately a 1-minute walk to 5601 Fishers Lane. Start going east on Twinbrook Pkwy toward Chapman Ave, then turn right on Fishers lane. Make the first left turn to access the parking garage. You may park in the garage at a daily rate of $7.00.


Presentation

Requirement: For your convenience, a laptop computer, LCD projector, and screen will be available. You may bring your presentation to the meeting on a memory stick to upload to the computer. Please note, all stick/flash/USB drives will need to be scanned by our IT department. To expedite this process, you should limit the data that is saved to the memory device. If you would like us to provide printed handouts of your OPEN session PowerPoint presentation to the DSMB Board members, please provide the electronic file to Steven Towers at no later than Thursday, May 7, 2015.

Important Deadlines: April 24, 2015 – Deadline to register

May 7, 2015 – Deadline to provide electronic copy of presentation

Contact Information: For agenda-related questions, please contact:

Delta Saint-Vil, Contractor

DSMB Team Leader/Project Manager

NIAID HIV/AIDS Scientific & Operations Support

Henry M. Jackson Foundation

Phone: 240.292.4653 Mobile: 240.421.8456 Fax: 240.627.3467

E-mail:

Steven Towers, Contractor

DSMB Project Analyst

NIAID HIV/AIDS Scientific & Operations Support

Henry M. Jackson Foundation

Phone: 240.292.4803 Mobile: 240.543.1180 Fax: 240.627.3467

E-mail:

For logistical or travel-related questions and to make any special accessibility requests (e.g., sign interpretation, wheelchair ramp access, etc.), please contact:

Susan Kerin, Contractor

Capital Consulting Corporation

Phone: 301.675.9518 Mobile: 301.675.9518 Fax: 301.881.1734

E-mail:

Multinational DSMB Study Team Factsheet – May 2015 Page 1 of 4