Effect of Male Circumcision on HIV Incidence (ANRS 1265)

This study has been terminated.

(following DSMB recommandation.)

Sponsor:

Information provided by:

French National Agency for Research on AIDS and Viral Hepatitis

ClinicalTrials.gov Identifier:

NCT00122525

First received: July 19, 2005

Last updated: April 29, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2005

Last Updated Date

April 29, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Measure the protective effect of medicalized male circumcision on HIV infection [ Time Frame: M3, M12 and M21 ]

Original Primary Outcome Measures ^ICMJE

Measure the protective effect of medicalized male circumcision on HIV infection at M3, M12 and M21.

Change History

Complete list of historical versions of study NCT00122525 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infections
Herpes Genitalis
Venereal Diseases

Intervention ^ICMJE

Procedure: Male Circumcision

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

3274

Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

18 Years to 24 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT Number ^ICMJE

NCT00122525

Other Study ID Numbers ^ICMJE

ANRS 1265

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Bertran Auvert, MD	Hôpital Ambroise-Paré (AP-HP); Inserm U687
Principal Investigator:	Adrian Puren	NICD, Johannesburg, South Africa

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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