Study Documents

The HPTN 046 study team has made the following study documents available.  New documents will be posted here as they become available.

HPTN 046 Protocol

• HPTN 046 Protocol v 3.0 (PDF)
• Summary of Changes v 2.0 – v 3.0 (PDF)
• Protocol Signature Page v 3.0 (PDF)
• HPTN 046 Protocol v 2.0 (PDF)
• Summary of Changes v 1.0 – v 2.0 (PDF)
• Protocol Signature Page v 2.0 (PDF)
• HPTN 046 Protocol v 1.0 (PDF)

HPTN 046 Letters of Amendment

• HPTN 046 v 3.0 LoA #1, 16 April 2008 (PDF)
• HPTN 046 v 2.0 LoA #1, 14 June 2007 (PDF)
• HPTN 046 v 1.0 LoA #1, 6 July 2004 (PDF)

HPTN 046 Clarification Memos

• HPTN 046 v 3.0 Clarification Memo #1, 26 February 2008 (PDF)
• HPTN 046 v 2.0 Clarification Memo #2, 09 May 2007 (PDF)
• HPTN 046 v 2.0 Clarification Memo #1, 26 January 2006 (PDF)
• HPTN 046 v 1.0 Clarification Memo #1, 7 April 2004 (Word)

HPTN 046 Case Report Forms

Please contact Diana Lynn at SCHARP to obtain the latest version of the HPTN 046 CRFs

HPTN 046 Study Specific Procedures Manual (SSP) (PDF)

• HPTN 046 SSP version 5.0 (zip)
• Table of Contents
• 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
• Section 8: Study Product Responsibilities for Non-Pharmacy Staff
• Section 9: Clinical and Counseling Procedures
• Section 10: Laboratory Procedures
• Section 11: Adverse Event Reporting and Safety Monitoring
• Section 12: Data Collection (19 Sep 2008)
• Section 13: Reporting Plan for HPTN 046
• Data Communiqués
  • Data Communiqué 10 (11 Dec 2008)
  • Data Communiqué 9 (3 Nov 2008)
  • Data Communiqué 8 (19 Sep 2008)
  • Data Communiqué 7 (8 Aug 2008)
  • Data Communiqué 6 (30 May 2008)
  • Data Communiqué 5 (14 May 2008)
  • Data Communiqué 4 (10 Mar 2008)
  • Data Communiqué 3 (13 Aug 2007)
  • Data Communiqué 2 (28 Jun 2007)
  • Data Communiqué 1 (26 Mar 2007)
• Appendices
  • DAIDS SOP for Essential Documents
  • DAIDS SOP for Source Documents
  • Sample Study Staff Roster and Signature Sheet
  • Sample Randomization Log and Sample Screening and Enrollment Log
  • DAIDS Adult and Pediatric Toxicity Table
  • HPTN 046 Supplemental Toxicity Table for Grading Fever, Malnutrition, and Rash
  • Protocol Safety Review Team Procedures and Query Form
  • Toxicity Management Table
  • EAE Reporting Manual, EAE Form, and Form Instructions
  • AE Reporting and Documentation Requirements Table
  • Procedures for Participants Enrolled under Protocol Version 2.0

HPTN 046 Site-Specific Study Operating Procedure (SOP) Templates

• SOP Content Guidelines (Word)
• SOP Template for Obtaining Informed Consent (Word)
• SOP Template for Participant Accrual (Word) 
• SOP Template for Participant Eligibility Determination (Word)
• SOP Template for Participant Retention (Word)
• SOP Template for Safety Monitoring and Adverse Event Reporting (Word)
• SOP Template for Source Documentation (Word)

HPTN 046 Safety Monitoring, Adverse Event Reporting, and Protocol Deviation Reporting

• HPTN 046 Toxicity Management Procedures  (Word)
• HPTN 046 Supplemental Table for Grading the Severity of Cutaneous/Skin Rash/Dermatitis, Malnutrition and Fever (Word)
• Viramune (nevirapine) Package Insert (PDF)
• DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF)
• Protocol Deviation Form (Word)
• Expedited Adverse Experience Form for version 3.0 (Word)

HPTN 046 Sample Forms and Documents

• Sample HPTN 046 Informed Consent Coversheet (Word)
• Sample HPTN 046 Informed Consent Assessment Tool (Word) (14 Apr 2008)
• Informed Consent Verification Statement (Word) (10 Oct 2007)
• Sample Source Documentation Table (Word)
• Suggested Filing Structure for HPTN 046 Essential Documents (Word) 

HPTN 046 Resources

• HPTN Manual of Operations