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

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:

MedlinePlus related topics: Genital Herpes HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

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:

Sponsor web page This link exits the ClinicalTrials.gov site

Publications:

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. Erratum in: PLoS Med. 2006 May;3(5):e298.

Sobngwi-Tambekou J, Taljaard D, Nieuwoudt M, Lissouba P, Puren A, Auvert B. Male circumcision and Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis: observations after a randomised controlled trial for HIV prevention. Sex Transm Infect. 2009 Apr;85(2):116-20. doi: 10.1136/sti.2008.032334. Epub 2008 Dec 15.

Sobngwi-Tambekou J, Taljaard D, Lissouba P, Zarca K, Puren A, Lagarde E, Auvert B. Effect of HSV-2 serostatus on acquisition of HIV by young men: results of a longitudinal study in Orange Farm, South Africa. J Infect Dis. 2009 Apr 1;199(7):958-64. doi: 10.1086/597208.

Auvert B, Sobngwi-Tambekou J, Cutler E, Nieuwoudt M, Lissouba P, Puren A, Taljaard D. Effect of male circumcision on the prevalence of high-risk human papillomavirus in young men: results of a randomized controlled trial conducted in Orange Farm, South Africa. J Infect Dis. 2009 Jan 1;199(1):14-9. doi: 10.1086/595566.

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. doi: 10.1371/journal.pone.0002679.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, Taljaard D, Puren A, Agot K, Serwadda D, Parker CB, Wawer MJ, Bailey RC. Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS. 2009 Jul 31;23(12):1557-64. doi: 10.1097/QAD.0b013e32832afe95.


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 February 25, 2015