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 V 3.0 (PDF) [A4] [U.S. Letter]
• Summary of Changes V2.0 - V3.0 (PDF) [A4] [U.S. Letter]
• HPTN 052 V 2.0 (PDF) [A4] [U.S. Letter]
• Summary of Changes V1.0 - V2.0 (PDF) [A4] [U.S. Letter]
• HPTN 052 V 1.0 (PDF) [A4] [U.S. Letter]

HPTN 052 Letters of Amendment

• 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 V 2.0 CM #1, 24 Sept 2004 (PDF) [A4] [U.S. Letter]
• HPTN 052 V 2.0 CM #2, 24 Dec 2004 (PDF) [A4] [U.S. Letter]
• HPTN 052 V 3.0 CM #1, 26 Aug 2009 (PDF) [A4] [U.S. Letter]

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.

• CRF Source Documentation Table (Word) (6 Jan 2009)

HPTN 052 Study Specific Procedures Manual (SSP)
All SSP Sections are PDF files unless otherwise noted.

• Summary of Changes v 1.5 to 1.6 (6 Jan 2009)
   
• Notifications of Change:

  	4 December 2009	Addition of Section 5.5.10 to HPTN 052 Study-Specific Procedure
  	27 August 2009	Confirmation of CD4+ cell count measurement for participants in the delay arm when an initial CD4+ cell count measurement is between 200 and 250 cells/mm3

  	24 August 2009	Addition of ritonavir (Norvir) to the list of study-provided drugs, Use of LPV/r (Kaletra/Aluvia) during breastfeeding, and Use of ritonavir (Norvir) to boost ATV in second-line therapy.
  	14 July 2009	Handling Medical Information Disclosed During Counseling and Clarifying Required Visits Following ART Initiation
  	20 May 2009	Inclusion Criteria for Women on ART for pMTCT and Additional Information for the Use of Boosted and Unboosted Atazanavir
  	4 Feb 2009	Target and Allowable Visit Windows

   

        
   

• Data Communiques:

  	10 Dec 2009	Data Communique #9
  	20 July 2009	Data Communique #8
  	10 Apr 2009	Data Communique #7
  	27 Mar 2009	Data Communique #6

   

• Lab Communiqués

  	14 Sep 2009	PTN NL Communiqué #2 to HPTN 052 SSP, V. 1.6
  	30 Mar 2009	PTN NL Communiqué # 1 to HPTN 052 SSP, V. 1.6

  
   

• HPTN 052 SSP v 1.6 (ZIP) (6 Jan 2009)
  • Front Matter
  • Section 1: Introduction
  • Section 2: Protocol
  • Section 3: Documentation Requirements
  • Section 4: Participant Accrual
  • Section 5: Participant Follow-up
  • Section 6: Visit Checklists
  • Section 7: Participant Retention and Termination
  • Section 8: Study Product Considerations
  • Section 9: Clinical and Counseling Procedures
  • Section 10: Laboratory Procedures
  • Section 11: Data Collection and Data Management
  • Section 12: Data Communiqués

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 16 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.

• Protocol Chair: Mike Cohen

• Site Investigator of Record: site specific

• Site Study Coordinator: site specific

• Site Quality Assurance/Quality Control Coordinator: site specific

• CORE Clinical Research Managers and Protocol Specialists: Theresa Gamble, Marybeth McCauley, Jackie Talley

• SDMC Project Manager: Leslie Cottle

• NL (Network Laboratory) representative: Estelle Piwowar-Manning

• Member of PSB (Prevention Science Branch at DAIDS): Alain Kouda

• DAIDS Medical Officer: Vanessa Elharrar

• *PAB (DAIDS Pharmaceutical Affairs Branch) representatives: Ana Martinez

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

HPTN 052 Safety Information

• Epivir® (lamivudine or 3TC)  Package Insert
• Combivir® (lamivudine/zidovudine combination) Package Insert
• Videx® EC (didanosine) Package Insert
• Viramune® (nevirapine) Package Insert
  • "Dear Investigator" letter from Boehringer Ingelheim, to accompany Viramune Package Insert (PDF)
• Reyataz® (atazanavir sulfate) Package Insert
• Zerit® (stavudine or d4T) Package Insert
• Sustiva® (efavirenz) Package Insert
• Viread® (tenofovir disoproxil fumarate) Package Insert
• Truvada® (emtricitabine and tinofiovir disoproxil fumarate) Package Insert
• Kaletra® (lopinavir/ritonavir) Package Insert

HPTN 052 Source Documentation and Forms
Documents are MS Word files unless otherwise noted.

• Visit Checklists (6 Jan 2009)
  • Screening: Potential Index or Partner Part 1
  • Screening: Potential Index Part 2
  • Screening: Potential Partner Part 2
  • Enrollment: Index
  • Enrollment: Partner
  • ART Initiation: Index
  • ART Initiation: Partner
  • Post-ART Initiation Visit: Index
  • Post-ART Initiation Visit: Partner
  • Monthly Visit: Index
  • Monthly Visit: Partner
  • Quarterly Visit: Index
  • Quarterly Visit: Partner
  • Annual Visit: Index
  • Annual Visit: Partner
  • Partner Seroconversion: Index
  • Partner Seroconversion: Partner
  • Confirmed Virologic Failure: Index
  • Confirmed Virologic Failure: Partner
  • Unscheduled (Interim) Visit: Index
  • Unscheduled (Interim) Visit: Partner
  • Termination Visit: Index
  • Termination Visit: Partner
• Screening and Enrollment Log
• Screening and Enrollment Log (Excel)
• Eligibility Criteria Table
• Example HPTN 052 Locator Form
• Adherence Counseling Checklists
• Couples and HIV Counseling Checklists (24 May 2007)
• Informed Consent Cover Sheet
• Informed Consent Comprehensive Assessment
• Participant Tracking Sheet
• Example of HPTN 052 History and Physical Examination Form
• Example of HPTN 052 Screening for AIDS Defining Illnesses Form
• CRF Source Documentation Table (6 Jan 2009)

HPTN 052 Resources

• WHO Case Definitions of HIV For Surveillance and Revised Clinical Staging and Immunological Classification of HIV Related Disease in Adults and Children
  HPTN 052 Adverse Event Tracking Log (Word)
• HPTN 052 Clinical Problem Log (Word)
• HPTN 052 QC Audit Tool for When-to-Start Events (Word)
• HPTN 052 Counselors Guide to Couples Counseling (PDF) [A4) [U.S. Letter]
• HPTN 052 Counselor Adherence Manual (PDF) [A4] [U.S. Letter]
• HPTN 052 Physician Adherence Manual (PDF) [A4] [U.S. Letter]
• Appendix 60 (PDF) (Jan 2009) - Use to determine whether AEs have confirmed or probable diagnoses.
• Lab Value Converter - Use this link to access the Lab Value Converter located on the Frontier Science website
• Example of SD and CRF QA template  (Word)
• Example of monthly SD and CRF QA report template. (Word)
• ART Medication Code List (26-Mar-2009) (PDF)
• DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF with 2009 clarification)