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HPTN 052
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

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Study Information

HPTN 052 Protocol

HPTN 052 Letters of Amendment

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HPTN 052 SSP

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HPTN Lab

Fetal Bovine Serum (FBS) Ordering Information
A total of 295 bottles (500 ml) of the current lot of heat inactivated FBS have been placed on reserve with Gemini Bio-Products. Please note that the VQA and IQA validation testing of this lot for use in culture experiments has been completed and the results have been summarized.  The results of the VQA and IQA validation testing have been posted to the web at https://www.actgnetwork.org/lab_resources/vqareports.aspx. The company's certificate of analysis of the lot is available upon request.

The price per bottle of $197.00 will be extended through November 30, 2008.  This price includes shipping and handling, although there is an additional $25.00 dry ice fee. (There will be a shipping charge for orders under 5 bottles.)

Please note: If you are interested in taking advantage of the $197.00 price, you may pre-purchase the FBS and store it with Gemini for no additional charge.

***SPECIAL NOTICE FOR INTERNATIONAL ORDERS***

In addition to the above mentioned cost, there will be an International Processing Fee of $200.00 for orders up to 20 X 500 ml bottles. For orders more than 20 bottles, there will be an additional fee of $5.00 per bottle with a total maximum fee of $480.00. The International Processing Fee is for the special set-up and processing required for international shipments which are handled and coordinated by Gemini's Document Control department according to specific procedures and guidelines set forth by both the USDA and Customs Authorities of each country for each recipient laboratory.

Please have the following information ready when placing your order:

  • Call: 1-800-543-6464 ext. 1 for customer service
  • Fax: 1-916-273-5222
  • Quotation number: 0282380
  • Customer number: ACTGHUS
  • Lot #: A61101C 

If you have any specific questions relating to the FBS, please contact John Polan at Gemini Bio-Products at 1-800-543-6464 ext. 3054 or via email at jpolan@gembio.com.

 

TearFloTM Test Strip Ordering Information
TearFloTM Tear Test Strips may be obtained by calling Wilson Ophthalmic at 1800-222-2020 (toll free phone number for U.S. sites) or 1-405-376-9114 (phone number for international sites), faxing them at 405-376-9133, or by setting up an account through their website (www.hilco.com). The catalog number for the product is #060-0000002-00, there are 100 strips per box, and the price is $14.95 per box (price quote as of 15 August 2005). A discount is available if 10 boxes or more are purchased at one time. Please note: One box should be sufficient for the run-in period of HPTN 052.

 

Shipping Specimens to the Central Lab – QA Testing and Remote Testing

As indicated in Section 10.7 of the HPTN 052 SSP Manual, the following types of samples will be shipped to the HPTN Central Laboratory: cervical Tear-Flo strips for HIV-1 RNA, seminal plasma for HIV-1 RNA, and genital ulcer swab for multiplex PCR. In addition, plasma samples for QA testing will be sent to the Central Lab

 

QA Testing Shipping Schedule

During the run-in phase of the study, once your site has enrolled 5 couples, one plasma aliquot on the index and one plasma aliquot on the partner should be shipped to the Central Lab. When you have completed the enrollment of the 10 couples, we ask that you send the final 5 couples’ aliquots. For sites that are also participating in the HPTN 035 study, please combine your 052 and 035 specimens for QA testing into one shipment.

 

Remote Testing Shipping Schedule

Throughout the course of HPTN 052, the following types of samples will be shipped to the HPTN Central Laboratory: cervical Tear-Flo strips for HIV-1 RNA, seminal plasma for HIV-1 RNA, and genital ulcer swab for multiplex PCR. International sites should send these samples to the HPTN Central Laboratory whenever they accumulate 15 specimens. U.S. sites may send these samples in real time. Different types of samples can be sent in the same shipment to the HPTN Central Laboratory.

 

Shipping Procedures

The frozen samples should be placed in the cryovial box in the order of the shipping manifest for shipments of 15 vials or more. If less then 15 vials are to be sent, they can be placed in plastic shipping baggies inside the orange topped shipping canister. A photocopy of the Specimen Tracking Sheet should accompany the specimen to the laboratory as well as shipping manifest, boxmap, and LDMS diskette.

 

The orange-topped canister should have absorbent material included. This is then placed in its cardboard box, which is placed inside the shipping box and the box filled with sufficient carbon dioxide (dry ice) to last at least 48 hours. If shipping more than 15 vials, wrap the box in absorbent material and place inside a shipping bag, seal, and place in the shipping container. Samples should be shipped as diagnostics packing code 650, UN 3373. If the site has any questions regarding ordering and purchasing of the appropriate shipping boxes, please contact your local courier company. Please consult your affiliate U.S. institution if you are having trouble obtaining this item.

 

Prior to shipment, please contact Estelle Piwowar-Manning at 410-614-6736 (phone), 410-614-0430 (fax) or epiwowa@jhmi.edu to set up the shipment with World Courier.

Any questions relating to specimen handling, shipping, or identification should be directed to Estelle Piwowar-Manning at 410-614-6736.

 

Shipping Address

The Johns Hopkins University Hospital

c/o Estelle Piwowar-Manning

Department of Pathology

Pathology Building -Room 313

600 North Wolfe Street

Baltimore, Maryland 21287

USA

 

Genotyping Shipments

For 052 Genotyping shipments to South Africa, please replace Shelly Cooks name with Ischell Doddameade. Please email the following people when shipping:

 

LDMS Materials

 

Laboratory Inventory
To use the Laboratory Inventory Worksheet, click the link, save the Excel file to your personal system, complete the inventory, and email it to the Network Lab.  The inventory must be updated monthly and resubmitted to the Network Lab via email. This procedure may be adjusted in the months ahead;  you will be notified by the Network Lab when the change occurs.

      

Send any questions or comments regarding this site to: hptn@fhi.org
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National Institute of Allergy and Infectious Diseases

This page was last updated: November 05, 2008