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| Descriptive Information Fields | |||||||||
| Brief Title † | Effect of Male Circumcision on HIV Incidence (ANRS 1265) | ||||||||
| Official Title † | Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration | ||||||||
| Brief 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. |
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| Detailed Description | This study is a randomized controlled intervention trial. This multi-centre study will take place in 3 centers located around Johannesburg, in the areas of Orange Farm, Sebokeng and Evaton. The intervention group patients (circumcised at the beginning of the trial) and the control group (uncircumcised men) will be followed during 21 months (from M.0 to M. 21). Randomization and medicalized circumcision will be performed at M.0 in the intervention group and might be optional in the control group at end of study. The medicalized circumcision effectiveness will be evaluated on and after M.3 (3 months after medicalized circumcision). Incidences (of HIV, HSV-2 infections and genital ulcer disease) will be compared from M.3 to M.21 between the intervention group and the control group. An intermediate analysis will take place at M. 12. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Measure the protective effect of medicalized male circumcision on HIV infection [ Time Frame: M3, M12 and M21 ] | ||||||||
| Secondary Outcome Measure † | Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2) [ Time Frame: M3, M12 and M21 ] Measure the protective effect on the incidence of genital ulcer disease [ Time Frame: M3, M12 and M21 ] |
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| Condition † | HIV Infections Herpes Genitalis Venereal Diseases |
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| Intervention † | Procedure: Male Circumcision | ||||||||
| MEDLINE PMIDs | 16231970 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 3274 | ||||||||
| Start Date † | July 2002 | ||||||||
| Completion Date | July 2005 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 24 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | South Africa | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00122525 | ||||||||
| Organization ID | ANRS 1265 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | French National Agency for Research on AIDS and Viral Hepatitis | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | French National Agency for Research on AIDS and Viral Hepatitis | ||||||||
| Verification Date | July 2007 | ||||||||
| First Received Date † | July 19, 2005 | ||||||||
| Last Updated Date | July 2, 2007 | ||||||||
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