Study Status Table

Studies & Sites Table

Studies by Country

Studies by Research Area

Study Phase Definitions

HPTN 057
A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants

Study Documents

The HPTN 057 study team has made the following study documents available.  New documents will be posted here as they become available.

HPTN 057 Protocol

• HPTN 057 Protocol v 1.0 and successive documents (PDF)
• HPTN 057 Protocol Signature Page v 1.0 (Word)

HPTN 057 Study Specific Procedures Manual

• HPTN 057 SSP Manual v 3.0 Zip File (28 Sep 2007)

• Change Log  (Word) (PDF) (28 Sep 2007)

• Front Matter

  • Inside Front Cover (Word) (PDF) (28 Sep 2007)

  • Acronym List (Word) (PDF) (28 Sep 2007)

• Table of Contents (Word) (PDF) (28 Sep 2007)

• Section 1  Introduction (Word) (PDF) (28 Sep 2007)

• Section 2  Protocol (PDF)

• Section 3  Documentation Requirements (Word) (PDF) (28 Sep 2007)

• Section 4  Participant Accrual (Word) (PDF) (28 Sep 2007)

• Section 5  Participant Follow-up (Word) (PDF) (28 Sep 2007)

• Section 6  Visit Checklists (Word) (PDF) (28 Sep 2007)

• Section 7  Retention (Word) (PDF) (28 Sep 2007)

• Section 8  Study Product Considerations (Word) (PDF) (28 Sep 2007)

• Section 9  Clinical and Counseling Procedures (Word) (PDF) (28 Sep 2007)

• Section 10  Laboratory Procedures (Word) (PDF) (28 Sep 2007)

  • Network Lab Communiqué #1 (20 Jul 2007)

  • Network Lab Communiqué #2 (31 Oct 2007)

• Section 11  Adverse Event Reporting and Safety Monitoring (Word) (PDF) (28 Sep 2007)

• Section 12  DataFax (PDF) (24 Oct 2006)

• Section 13  Reporting Plan for HPTN 057 (PDF) (24 Oct 2006)

• Section 14  Data Communiqués

  • Data Communiqué #1 (3 May 2007)

  • Data Communiqué #2 (18 Jul 2007)

HPTN 057 Case Report Forms

Please contact Lynda Emel at SCHARP to obtain the latest version of the HPTN 057 CRFs

HPTN 057 Study Implementation Documents and Resources

• Study Activation Requirements (Word)
• IRB Submission Requirements Table (Word)
• Sample HPTN 057 Informed Consent Coversheet (Word)
• Sample Source Documentation Table (Word)
• Sample HPTN 057 Study Staff Roster and Signature Sheet (Word)
• Sample HPTN 057 Screening and Enrollment Log (Excel)
• Suggested Filing Structure for HPTN 057 Essential Documents (Word)
• Protocol Deviation Form (Word)

HPTN 057 Site-Specific Study Operating Procedures (SOPs)

• SOP Content Guidelines (Word)
• SOP Template (Word)

HPTN 057 Safety Monitoring and Adverse Event Reporting

• HPTN 057 Supplemental Table for Grading the Severity of Malnutrition and Fever (Word)
• Viread® (tenofovir disoproxil fumarate) Tablets Package Insert (PDF), March 2006 (PDF)
• HPTN 057 PSRT AE Notification Form (Word)
• HPTN 057 Pausing Procedures (PDF)
• DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
• Manual for Expedited Reporting of Adverse Events to DAIDS
• HPTN 057 Specific DAIDS Expedited Adverse Event Report Form (Word)
• DAIDS Expedited Adverse Event Report Form Instructions

HPTN 057 Resources

• HPTN Manual of Operations
• DAIDS Standard Operating Procedures for Essential Documents and Source Documentation

Send any questions or comments regarding this site to: hptn@fhi.org
Please read the HPTN Disclaimer