Effect of Male Circumcision on HIV Incidence (ANRS 1265)

NCT00122525 | Terminated Phase 3 DMC

• 1 other identifier: ANRS 1265
• Study Type: interventional
• Target: 3,274
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Herpes Genitalis; Venereal Diseases

Keywords

HIV; Male circumcision; Prevention; HSV-2; Africa; Sexual behavior

Outcome Measures

Primary Outcomes (1)

• Measure the protective effect of medicalized male circumcision on HIV infection

  M3, M12 and M21

Secondary Outcomes (2)

• Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2)

  M3, M12 and M21

• Measure the protective effect on the incidence of genital ulcer disease

  M3, M12 and M21

Interventions

Male Circumcision PROCEDURE

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Men with AIDS
• Men with contraindication for circumcision
• Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

MC Centre

Orange Farm, Johannesburg, South Africa

Location

Related Publications (6)

• 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.

  PMID: 18682725 BACKGROUND

• 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. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.

  PMID: 16231970 RESULT

• 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.

  PMID: 19074928 RESULT

• 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.

  PMID: 19220143 RESULT

• 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.

  PMID: 19086814 RESULT

• 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.

  PMID: 19571722 DERIVED

Related Links

• Sponsor web page

MeSH Terms

Conditions

HIV Infections; Herpes Genitalis; Sexually Transmitted Diseases; Sexual Behavior

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Bertran Auvert, MD

  Hôpital Ambroise-Paré (AP-HP); Inserm U687

  STUDY CHAIR

• Adrian Puren

  NICD, Johannesburg, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2002
• Study Completion: July 1, 2005
• Last Updated: April 30, 2009

Record last verified: 2009-04

Locations

ZA (1)