Status:
TERMINATED
Effect of Male Circumcision on HIV Incidence (ANRS 1265)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Herpes Genitalis
Eligibility:
MALE
18-24 years
Phase:
PHASE3
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 ...
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 interv...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
3274 Patients enrolled
Trial Details
Trial ID
NCT00122525
Start Date
July 1 2002
End Date
July 1 2005
Last Update
April 30 2009
Active Locations (1)
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1
MC Centre
Orange Farm, Johannesburg, South Africa