Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Phase 3

Terminated

• Conditions: HIV Infections; Herpes Genitalis; Venereal Diseases

• Registration Number: NCT00122525
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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 Timeline

• Study Start: 2002-07
• Study Completion: 2005-07
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-29
• Last Update Posted: 2009-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3274

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure the protective effect of medicalized male circumcision on HIV infection	M3, M12 and M21

Secondary Outcome Measures

Name	Time	Method
Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2)	M3, M12 and M21
Measure the protective effect on the incidence of genital ulcer disease	M3, M12 and M21

Trial Locations

Locations (1)

MC Centre; 🇿🇦 Orange Farm, Johannesburg, South Africa