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Author Topic: Analysis of results from the Caprisa 004 tenofovir microbicide trial  (Read 1373 times)

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Offline newt

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The much reported tenofovir gel study is reported here:


"The combined rural/urban analysis produced a protection rate of 39% from using the active compared to placebo gel. However, the 95% confidence intervals are 6% and 60%. Further studies are likely to focus on dosing, adherence and other factors in order to see whether higher protection rates can be seen. Although the results were presented by site, showing effectiveness at the rural site of 43% (95%CI 5, 57; p=0.023) but not at the urban site (26%; 95%CI 59, 67; p=0.380) .... However, as the study was not designed to compare efficacy by site, while interesting, it was not powered for this comparison to be meaningful."

Of note is this comment from the author of the report:

"The differences in the urban/rural results may just be an issue of overall sample size (as opposed to something connected to the difference in lifetime sex partners or other factors). A good precedent for caution over the adherence analysis however comes from an earlier microbicide study. A similar adherence analysis in the phase 2b PRO2000 HPTN 035 study showed protection rates of 9%, 44% and 78% in low gel users, high gel users, and low condom/high gel users, respectively. Yet this microbicide was subsequently shown not to work.

"Of note, the findings on prevention of HSV-2 transmission were more significant and robust than protection against HIV, and this will clearly be the focus for further research study."

- matt
"The object is to be a well patient, not a good patient"


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