|
Date
|
Event
|
|
February 1996
|
Investigational new drug application #49,991 opened by DAIDS and later reviewed and accepted by FDA
|
|
July 1997
|
Protocol approved by Johns Hopkins Joint Committee on Clinical Investigation (JCCI) and Ugandan AIDS Research Committee (ARC)
|
|
|
Data and Safety Monitoring Board (DSMB) meeting (July 1, 1997)
|
|
August 1997
|
Protocol version 1.0 sent to FDA
|
|
November 1997
|
HIVNET 012 enrollment begins
|
|
February 1998
|
Enrollment stopped; placebo arms are dropped (Amendment I to Protocol Version 1.0)
|
|
March 1998
|
Investigators ask JCCI and ARC to approve redesigned study
|
|
April 1998
|
Enrollment begins into revised protocol
|
|
May 1998
|
Enrollment stopped because of drug unavailability and drug packaging issue
|
|
July 1998
|
Enrollment resumes into 2-arm trial
DSMB meeting (July 16, 1998)
|
|
April 1999
|
HIVNET 012 enrollment completed
|
|
June 1999
|
DSMB meeting (June 24, 1999)
|
|
July 1999
|
DSMB telephone conference (July 12, 1999)
|
|
September 1999
|
Early results of HIVNET 012 published in The Lancet
|
|
April 2000
|
Protocol amended to follow women and infants for 5 years (Amendment II to Protocol Version 1.0)
|
|
June 2001
|
Boehringer Ingelheim (BI) submits supplemental new drug application (sNDA) for NVP to FDA
|
|
January 2002
|
BI study site visit
|
|
February 2002
|
Westat study site visit
|
|
March 2002
|
BI withdraws NVP sNDA
|
|
July to December 2002
|
DAIDS audit (remonitoring) of HIVNET 012
|
|
March 2003
|
DAIDS remonitoring report released
|
|
September 2003
|
Second Lancet paper published
|
|
September 2004
|
IOM committee convened
|
