NCT00122525

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,274 (actual)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: Male
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections
• Herpes Genitalis
• Venereal Diseases

Interventions

Type	Name	Description
PROCEDURE	Male Circumcision

Timeline

• Start date: 2002-07-01
• Completion: 2005-07-01
• First posted: 2005-07-22
• Last updated: 2009-04-30

Locations

1 site across 1 country: South Africa