Review of the HIVNET 012 Perinatal HIV Prevention Study (2005) / Chapter Skim
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2 Overview of HIVNET 012
2 Overview of HIVNET 012
Pages 18-26
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From page 18... ...
Centers for Disease Control and Prevention in Thailand of 393 mother/infant pairs showed that a short course of oral ZDV could reduce HIV-1 transmission by about 50% over a placebo -- to an overall rate of 10% -- in a non-breastfeeding population (CDC, UNAIDS, NIH, and NRS, 1998; Shaffer et al., 1999) .1 As a result, HIVNET 012 researchers formally dropped the placebo arms in a letter of amendment 1The target sample size of 392 women had the ability to detect a 50% reduction in transmission risk -- from 24% to 12% -- with 80% power and a Type I error rate of 5% (Shaffer et al., 1999)
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From page 19... ...
Positive test results were confirmed by a quantitative HIV-1 RNA PCR assay3 or HIV-1 culture on a second blood sample. For infants who tested positive for HIV-1, the quantitative HIV-1 RNA PCR assay was performed at each scheduled 2A Phase IIb trial is sometimes viewed as an intermediate safety and efficacy trial.
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From page 20... ...
in response to findings in other studies that some women could develop viral resistance to NVP, and that some children treated with various antiretroviral drugs in utero or perinatally could possibly experience mitochondrial toxicity. The modification entailed extending follow-up of women in the NVP arm and all children in the 18-month study to 5 years, with yearly evaluations for NVP resistance in women who had received NVP (HIVNET 012 Investigators, 2000)
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From page 21... ...
21 if Days, chance by 13 red Ages occur value value at P 0.35 0.0027 0.0006 P 0.17 0.0012 0.0002 have Death would or result Death (8.2%)
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This paper analyzed adverse events and serious adverse events more completely, reporting that both types of events among mothers up to 56 days were balanced between the study arms. Three deaths occurred among women assigned to the ZDV arm, but all were judged related to complications of HIV-1 infection.
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23 18 and 12 Ages value value at P 0.0083 0.0023 P 0.0076 0.0048 Death or Death (15.3%)
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0 (0.0%) 0.08 Infants Total 309 320 First 8 weeks All adverse events 288 (93.2%)
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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)
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From page 26... ...
1997. Protocol HIVNET 012: A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Preg nant Ugandan Women and Their Neonates.
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