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Effect of Male Circumcision on HIV Incidence (ANRS 1265)

NCT ID: NCT00122525

Last Updated: 2009-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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HIV Infections Herpes Genitalis Venereal Diseases

Keywords

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HIV Male circumcision Prevention HSV-2 Africa Sexual behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Male Circumcision

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Bertran Auvert, MD

Role: STUDY_CHAIR

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

Adrian Puren

Role: PRINCIPAL_INVESTIGATOR

NICD, Johannesburg, South Africa

Locations

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MC Centre

Orange Farm, Johannesburg, South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type BACKGROUND
PMID: 18682725 (View on PubMed)

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.

Reference Type RESULT
PMID: 16231970 (View on PubMed)

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.

Reference Type RESULT
PMID: 19074928 (View on PubMed)

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.

Reference Type RESULT
PMID: 19220143 (View on PubMed)

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.

Reference Type RESULT
PMID: 19086814 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19571722 (View on PubMed)

Related Links

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http://www.anrs.fr

Sponsor web page

Other Identifiers

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ANRS 1265

Identifier Type: -

Identifier Source: org_study_id