Review of the HIVNET 012 Perinatal HIV Prevention Study (2005) / Chapter Skim
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6 Response to the Charge to the Committee
6 Response to the Charge to the Committee
Pages 98-108
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From page 98... ...
, the Institutes of Medicine will conduct an independent review of the HIVNET 012 clinical trial conducted in Uganda.
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From page 99... ...
Chapters 3 and 4 provide a detailed discussion of both the initial and modified design of HIVNET 012. In view of the enormous burden of mother-to-child transmission of HIV-1 in sub-Saharan Africa -- which remains a critical public health problem -- and the need to identify regimens that can be delivered widely to HIV-infected pregnant women with limited access to health care, the effort of HIVNET 012 investigators to study new regimens suitable for widespread use in a resource-poor setting was appropriate.
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From page 100... ...
Thus the design of 1At the time of the HIVNET 012 study, the only regimen available for preventing motherto-child transmission was from the Pediatric AIDS Clinical Trials Group (PACTG) 076 trial.
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From page 101... ...
The Department of Health and Human Services (DHHS) has adopted additional regulations that specifically address research with pregnant women.
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From page 102... ...
These observations indicate a high degree of adherence in the NVP arm. Because ZDV has a short half-life of 1.1 hours in non-pregnant women and possibly a shorter half-life in pregnant women, obtaining direct evidence of blood levels of ZDV in those assigned to ZDV therapy was not feasible.
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From page 103... ...
to be predominantly, but not solely, hospitalizations, severe laboratory toxicities, life-threatening illness, and death, which was a reasonable interpretation based on the background rates of illness in Uganda. As a result, conditions that might have been judged to be serious by other investigators in resource-rich countries but did not result in hospitalization in Uganda may not have been recorded as serious adverse events by the HIVNET 012 investigators.
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From page 104... ...
In this review, the committee found some evidence of underreporting of concomitant serious adverse events present when an SAE was reported. However, if a participant's source documents showed one or more serious adverse events had occurred simultaneously, at least one of those events on that occasion was noted in the case report form and documented in the study database.
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From page 105... ...
RESPONSE TO THE CHARGE TO THE COMMITTEE 105 based on the body of information it reviewed, the committee concludes that the integrity of the study data can be supported.
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From page 106... ...
Based on the information summarized in this report, the committee concludes that the findings from HIVNET 012 regarding efficacy of NVP-including the reduction in rate of mother-to-child transmission of HIV-1 and HIV-1 infection-free survival at 46 weeks, 1416 weeks, and 18 months in the NVP arm -- are sound and fully supportable by the data. The reported high levels of adherence to treatment regimens can also be supported.
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From page 107... ...
Thus, the committee concludes that the investigators' findings regarding similarity of the rates of infant serious adverse events in the two treatment groups are supportable.
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From page 108... ...
1994. Reduction of maternal-infant transmis sion of human immunodeficiency virus type 1 with zidovudine treatment.
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