HPTN 046
Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
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
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HPTN 046 Protocol v 2.0 (PDF)
HPTN 046 Letters of Amendment
HPTN 046 Clarification Memos
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HPTN 046 v 3.0 Clarification Memo #3, 23 November 2009 (PDF)
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HPTN 046 v 3.0 Clarification Memo #2, 20 February 2009 (PDF)
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HPTN 046 v 3.0 Clarification Memo #1, 26 February 2008 (PDF)
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)
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HPTN 046 SSP version 5.0 (zip)
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Section 8: Study Product Responsibilities for Non-Pharmacy Staff
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Section 12: Data Collection (19 Sep 2008)
- Data Communiqués
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Data Communiqué 12 (14 Jan 2010)
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Data Communiqué 9 (3 Nov 2008)
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Data Communiqué 8 (19 Sep 2008)
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Data Communiqué 7 (8 Aug 2008)
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Data Communiqué 6 (30 May 2008)
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Data Communiqué 5 (14 May 2008)
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Data Communiqué 4 (10 Mar 2008)
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Data Communiqué 3 (13 Aug 2007)
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Data Communiqué 2 (28 Jun 2007)
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Data Communiqué 1 (26 Mar 2007)
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- Lab Communiqués
- Appendices
HPTN 046 Safety Monitoring, Adverse Event Reporting, and Protocol Deviation Reporting
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DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF with 2009 clarification)
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Protocol Deviation Form (Word)