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Effect of Male Circumcision on HIV Incidence (ANRS 1265)

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ClinicalTrials.gov Identifier: NCT00122525
Recruitment Status : Terminated (following DSMB recommandation.)
First Posted : July 22, 2005
Last Update Posted : April 30, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Herpes Genitalis Venereal Diseases Procedure: Male Circumcision Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration
Study Start Date : July 2002
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Measure the protective effect of medicalized male circumcision on HIV infection [ Time Frame: M3, M12 and M21 ]

Secondary Outcome Measures :
  1. Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2) [ Time Frame: M3, M12 and M21 ]
  2. Measure the protective effect on the incidence of genital ulcer disease [ Time Frame: M3, M12 and M21 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122525


Locations
South Africa
MC Centre
Orange Farm, Johannesburg, South Africa
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Study Chair: Bertran Auvert, MD Hôpital Ambroise-Paré (AP-HP); Inserm U687
Principal Investigator: Adrian Puren NICD, Johannesburg, South Africa
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00122525     History of Changes
Other Study ID Numbers: ANRS 1265
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: April 2009

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV
Male circumcision
Prevention
HSV-2
Africa
Sexual behavior

Additional relevant MeSH terms:
Infection
HIV Infections
Herpes Genitalis
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Genital Diseases, Male
Genital Diseases, Female