Review of the HIVNET 012 Perinatal HIV Prevention Study (2005) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 11-17
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 11... ...
These interventions include antiretroviral treatment of pregnant women and their infants, the selective use of elective cesarean delivery, and complete avoidance of breastfeeding (UNAIDS and WHO, 2004)
|
From page 12... ...
HIVNET 012 was one such study. Initiated in Uganda in 1997, HIVNET 012 was designed to provide preliminary information on the comparative safety and efficacy of two relatively simple and inexpensive short courses of oral antiretroviral treatment -- one involving ZDV, and the other nevirapine (NVP)
|
From page 13... ...
In February 2002, a team from Westat visited the study site and reviewed regulatory compliance, laboratory facilities, pharmacy facilities and processes, and trial records. The Westat team reported finding multiple problems with HIVNET 012, including procedural irregularities and issues with how investigators had defined, graded, and reported serious adverse events.
|
From page 14... ...
2Source documents included all clinical forms completed for each participant at the time of scheduled and unscheduled visits to the study clinic, and staff abstractions developed based on hospital admissions forms, before those became available to study staff. 3The audit reviewed 25,000 data points from the study database on a random sample of 80 mother/infant pairs stratified by location (including Old Mulago and New Mulago enrollees -- see Chapter 3)
|
From page 15... ...
The IOM committee is charged with addressing the following questions related to HIVNET 012: 1. Was the protocol design appropriate?
|
From page 16... ...
The committee's approach was informed by the recognition that study design and conduct must be assessed from the perspective of scientific validity and global standards for protecting human subjects. In Chapter 2, the committee provides more detail on how researchers conducted HIVNET 012 and a brief overview of the key events that occurred during and after the trial.
|
From page 17... ...
:2168-2169. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, JimenezE,O'Neill E, Bazin B, Delfraissy J, Culnane M, Coombs R, Elkins M, Moye J, Stratton P, Balsley J, for The Pediatric AIDS Clinical Trials Gropu Protocol 076 Study Group.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.