Effect of Male Circumcision on HIV Incidence (ANRS 1265) (NCT00122525) | Clinical Trial Compass
TerminatedPhase 3
Effect of Male Circumcision on HIV Incidence (ANRS 1265)
Stopped: following DSMB recommandation.
South Africa3,274 participantsStarted 2002-07
Plain-language summary
Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.
Who can participate
Age range18 Years – 24 Years
SexMALE
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Inclusion Criteria:
* Uncircumcised men aged 18-24 years
* Be in good general condition with normal physical and genital examinations
* Consenting to participate in the trial and to sign an informed consent
* Consenting to randomization of the medicalized circumcision schedule (performed at the beginning of study for the treated group, optional at the end of study for the control group)
* Consenting to avoid sexual contact (except with condom protection) during the 6 weeks following the medicalized circumcision
* Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 and syphilis.
Exclusion Criteria:
* Men with AIDS
* Men with contraindication for circumcision
* Men thinking of moving away from the trial sites within the 21 months following inclusion
* Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)
What they're measuring
1
Measure the protective effect of medicalized male circumcision on HIV infection
Timeframe: M3, M12 and M21
Trial details
NCT IDNCT00122525
SponsorFrench National Agency for Research on AIDS and Viral Hepatitis