Friday, July 17, 2009

The Lancet publishes results from Uganda trial: Showed that circumcising HIV+ men did not protect women

"Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial."

Maria J Wawer, Frederick Makumbi, Godfrey Kigozi, David Serwadda, Stephen Watya, Fred Nalugoda, Dennis Buwembo, Victor Ssempijja, Noah Kiwanuka, Lawrence H Moulton, Nelson K Sewankambo, Steven J Reynolds, Thomas C Quinn, Pius Opendi, Boaz Iga, Renee Ridzon, Oliver Laeyendecker, Ronald H Gray.

The Lancet, Volume 374, Issue 9685, Pages 229 - 237, 18 July 2009
DOI: 10.1016/S0140-6736(09)60998-3

Background: Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners.

Methods: 922 uncircumcised, HIV-infected, asymptomatic men aged 15—49 years with CD4-cell counts 350 cells per μL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with, number NCT00124878.

Findings: The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0·36). Cumulative probabilities of female HIV infection at 24 months were 21·7% (95% CI 12·7—33·4) in the intervention group and 13·4% (6·7—25·8) in the control group (adjusted hazard ratio 1·49, 95% CI 0·62—3·57; p=0·368).

Interpretation: Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention.

Funding: Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.

Read the full article

[IRMA reminds readers that two trials have shown that circumcised men were 50 to 60 percent less likely to get HIV from having (what is presumed to be mostly) vaginal sex. This does not mean that circumcised men cannot get or transmit HIV. It only means that they are about half as likely as uncircumcised men to get HIV from having vaginal sex with a woman who has HIV.

Trial data also do not show whether circumcision lowers the risk of transmission for either men or women during unprotected anal sex.]

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