Effect of Male Circumcision on HIV Incidence (ANRS 1265) - Full Text View

Sponsored by:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00122525

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 III

MedlinePlus related topics: AIDS Circumcision Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122525

Locations

South Africa, Johannesburg
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

Sponsor web page This link exits the ClinicalTrials.gov site

Publications of Results:

Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. Epub 2005 Oct 25.

Sobngwi-Tambekou J, Taljaard D, Nieuwoudt M, Lissouba P, Puren A, Auvert B. Male circumcision and Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: observations in the aftermath of a randomised controlled trial for HIV prevention. Sex Transm Infect. 2008 Dec 15; [Epub ahead of print]

Other Publications:

Auvert B, Marseille E, Korenromp EL, Lloyd-Smith J, Sitta R, Taljaard D, Pretorius C, Williams B, Kahn JG. Estimating the resources needed and savings anticipated from roll-out of adult male circumcision in Sub-Saharan Africa. PLoS ONE. 2008 Aug 6;3(8):e2679.

Study ID Numbers:	ANRS 1265
Study First Received:	July 19, 2005
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00122525
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

Study placed in the following topic categories:

Herpes Simplex
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Ulcer
Acquired Immunodeficiency Syndrome
Genital Diseases, Male
Immunologic Deficiency Syndromes

Herpesviridae Infections
Genital Diseases, Female
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009