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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

 

Study Documents

The HPTN 052 study team has made the following study documents available.  When possible, documents are presented in both A4 and U.S. Letter paper sizes.  New documents will be posted here as they become available.

HPTN 052 Protocol

 

HPTN 052 Letters of Amendment

  • HPTN 052 V 3.0, LoA #5, 10 May 2011 (PDF) [U.S. Letter]
  • HPTN 052 V 3.0, LoA #4, 9 Dec 2008 (PDF) [U.S. Letter]
  • HPTN 052 V 3.0, LoA #3, 30 Jul 2008 (PDF) [U.S. Letter]
  • HPTN 052 V 3.0, LoA #2, 20 March 2008 (PDF) [U.S. Letter]
  • HPTN 052 V 3.0, LoA #1, 7 August 2007 (PDF) [U.S. Letter]
  • HPTN 052 V 2.0, LoA #2, 13 July 2005 (PDF) [A4] [U.S. Letter]
  • HPTN 052 V 2.0, LoA #1, 23 December 2004 (PDF) [A4] [U.S. Letter]

 

HPTN 052 Clarification Memos

 

HPTN 052 Case Report Forms (CRFs)

CRFs, CRF packets, the ART Medication Code List, CRF Request Forms and Printing Instructions are located on the Atlas Science Portal. Please contact Leslie Cottle at SCHARP for further information or any questions.

 

HPTN 052 Protocol Deviation Reporting

Instructions for protocol deviation reporting for HPTN 052 can be found in Section 3 of the HPTN 052 SSP and in Section 12 of the HPTN MOP. Protocol deviation reports should be sent to the following distribution list.  Click on each person's name to access his contact information.

*If the deviation involves an investigational product, the DAIDS protocol pharmacist(s) should be included in the distribution list.

HPTN 052 Safety Information

Package Insert information for the study drugs listed below can found on the Regulatory Support Center website at the following link.

http://rsc.tech-res.com/safetyandpharmacovigilance/PIList.aspx

  • Epivir® (lamivudine or 3TC)  Package Insert
  • Combivir® (lamivudine/zidovudine combination) Package Insert
  • Videx® EC (didanosine) Package Insert
  • Viramune® (nevirapine) Package Insert
  • Reyataz® (atazanavir sulfate) Package Insert
  • Zerit® (stavudine or d4T) Package Insert
  • Sustiva® (efavirenz) Package Insert
  • Viread® (tenofovir disoproxil fumarate) Package Insert
  • Truvada® (emtricitabine and tenofiovir disoproxil fumarate) Package Insert
  • Kaletra® (lopinavir/ritonavir) Package Insert

 

HPTN 052 Source Documentation and Forms

Documents are MS Word files unless otherwise noted.

 

HPTN 052 Resources