Effect of Male Circumcision on HIV Incidence (ANRS 1265)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 3

Conditions

Venereal Diseases

HIV Infections

Herpes Genitalis

Treatments

Procedure: Male Circumcision

Study type

Interventional

Funder types

Other

Identifiers

NCT00122525

ANRS 1265

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,274 patients

Sex

Male

Ages

18 to 24 years old

Volunteers

Accepts Healthy Volunteers

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)