Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Last updated: April 29, 2009
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Overall Status: Terminated

Phase

3

Condition

Hiv Infections

Herpes Simplex Infections

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT00122525
ANRS 1265
  • Ages 18-24
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thebeginning of study for the treated group, optional at the end of study for the controlgroup)

  • Consenting to avoid sexual contact (except with condom protection) during the 6 weeksfollowing the medicalized circumcision

  • Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 andsyphilis.

Exclusion

Exclusion Criteria:

  • Men with AIDS

  • Men with contraindication for circumcision

  • Men thinking of moving away from the trial sites within the 21 months followinginclusion

  • Men with clinical sexually transmitted diseases (STDs) (those men could be includedafter treatment)

Study Design

Total Participants: 3274
Study Start date:
July 01, 2002
Estimated Completion Date:
July 31, 2005

Study 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.

Connect with a study center

  • MC Centre

    Orange Farm, Johannesburg
    South Africa

    Site Not Available

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