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Effect of Male Circumcision on HIV Incidence (ANRS 1265)

This study has been terminated.
Information provided by French National Agency for Research on AIDS and Viral Hepatitis

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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.

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.

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 ]
Condition  HIV Infections
Herpes Genitalis
Venereal Diseases
Intervention  Procedure: Male Circumcision
MEDLINE PMIDs 16231970
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  3274
Start Date  July 2002
Completion Date July 2005
Eligibility Criteria 

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)
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 
Study Chair:     Bertran Auvert, MD     Hôpital Ambroise-Paré (AP-HP); Inserm U687    
Principal Investigator:     Adrian Puren     NICD, Johannesburg, South Africa    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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