Back to results

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Primary Purpose

HIV Infections, Herpes Genitalis, Venereal Diseases

Status

Terminated

Phase

Phase 3

Locations

South Africa

Study Type

Interventional

Intervention

Male Circumcision

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Male circumcision, Prevention, HSV-2, Africa, Sexual behavior

Eligibility Criteria

18 Years - 24 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

MC Centre

Outcomes

Primary Outcome Measures

Measure the protective effect of medicalized male circumcision on HIV infection

Secondary Outcome Measures

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

Measure the protective effect on the incidence of genital ulcer disease

Full Information

NCT ID

NCT00122525

First Posted

July 19, 2005

Last Updated

April 29, 2009

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

1. Study Identification

Unique Protocol Identification Number

NCT00122525

Brief Title

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Official Title

Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Terminated

Why Stopped

following DSMB recommandation.

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Herpes Genitalis, Venereal Diseases

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3274 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Male Circumcision

Primary Outcome Measure Information:

Title

Measure the protective effect of medicalized male circumcision on HIV infection

Time Frame

M3, M12 and M21

Secondary Outcome Measure Information:

Title

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

Time Frame

M3, M12 and M21

Title

Measure the protective effect on the incidence of genital ulcer disease

Time Frame

M3, M12 and M21

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertran Auvert, MD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Adrian Puren

Organizational Affiliation

NICD, Johannesburg, South Africa

Official's Role

Principal Investigator

Facility Information:

Facility Name

MC Centre

City

Orange Farm

State/Province

Johannesburg

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

18682725

Citation

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.

Results Reference

background

PubMed Identifier

16231970

Citation

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

Results Reference

result

PubMed Identifier

19074928

Citation

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.

Results Reference

result

PubMed Identifier

19220143

Citation

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.

Results Reference

result

PubMed Identifier

19086814

Citation

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.

Results Reference

result

PubMed Identifier

19571722

Citation

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.

Results Reference

derived

Links:

URL

http://www.anrs.fr

Description

Sponsor web page

Learn more about this trial

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

We'll reach out to this number within 24 hrs