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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
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
July 19, 2005
Last Updated
April 29, 2009
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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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
Accepts Healthy Volunteers
Eligibility 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)
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

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Effect of Male Circumcision on HIV Incidence (ANRS 1265)

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