Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
San Francisco Chronicle - June 29, 2006
Sabin Russell, srussell@sfchronicle.com.
AIDS-prevention experts were wishing for a replay of a scenario that occurred last year: A South African medical committee halted a circumcision study after an early look at the data showed that the procedure reduced risk of HIV infection by at least 60 percent. The protective effect was so beneficial that scientists believed it would be unethical to continue the experiment and withhold the findings.
The results of the South African study involving 3,274 men were published in January in the journal PLoS Medicine by French researcher Bertran Auvert and colleagues in France and Johannesburg.
On Tuesday, however, the NIH committee monitoring similar studies in Kisumu, Kenya, and Rakai, Uganda, took a preliminary look at results of those two experiments and ruled they should continue until their scheduled completion next year.
Robert Bailey, the University of Illinois epidemiologist who is lead investigator of the Kenyan study, acknowledged that many people had high hopes that the study would be halted early. However, he said he's not surprised by the decision. "It was a misplaced hope," he said. "I was telling people it was highly unlikely."
Perhaps the only lasting effect of the decision to continue the studies until next year is that there will be no early release of the data for discussion at the 16th International AIDS Conference this August in Toronto. If upbeat findings had come out of Kisumu and Rakai, circumcision might have become the big news of the global AIDS meeting.
As it is, Bailey said the decision to continue the experiment without interruption is neither good news nor bad. "It doesn't mean we don't have a 60 percent figure, or better," he said. The interim results remain a secret, even to the investigators involved, because the trial is known as "blinded." Keeping the results under wraps until the experiment is ended assures the scientific integrity of the eventual findings.
Bailey said there is a possibility that the monitoring board will look at the data once again in six to eight months to determine if an early halt to the experiment is warranted.
The study involves 3,000 previously uncircumcised men in Kisumu, a region of Kenya where there is not a traditional circumcision practice. Half have subsequently been circumcised, and the others have their foreskins intact. At the end of the trial -- slated for September 2007, researchers will tally up the number who have become HIV-positive and those who remain negative in both groups.
Researchers at Johns Hopkins University and Columbia are leading the Rakai study, which is slated for completion in July 2007 and has enrolled 5,000 men.
Auvert's study in South Africa was stopped because an early peek at the data showed 49 of the uncircumcised men had become HIV-positive, compared with 20 in the circumcised group. That showed a protective effect of 60 percent, and further analysis of the data suggests it might be as high as 76 percent.
Dr. John Krieger, a University of Washington urologist who has been tracking the safety of the Kenyan trial, said he is not concerned about the failure to end the study early. The study, after all, was designed from the start to go on until next year.
"I would have loved for them to have stopped it," he said. "It's always nice to hit a home run in the World Series. But most of us are happy just to get a hit every once in a while."
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