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Effect of Male Circumcision on HIV Incidence (ANRS 1265)

This study has been terminated.
(following DSMB recommandation.)
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122525
First received: July 19, 2005
Last updated: April 29, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
HIV Infections
Herpes Genitalis
Venereal Diseases
Procedure: Male Circumcision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

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

Enrollment: 3274
Study Start Date: July 2002
Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: July 19, 2005
Last Updated: April 29, 2009
Health Authority: South Africa: National Health Research Ethics Council

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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Herpes Genitalis
Infection
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Female
Genital Diseases, Male
Herpes Simplex
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014