Effect of Male Circumcision on HIV Incidence (ANRS 1265) | NCT00122525

Studies
Effect of Male Circumcision on HIV Incidence (ANRS 1265)

NCT00122525

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Status

Terminated

Last Update Posted

Apr 30, 2009Estimated

Enrollment

3,274Actual

Phase

Phase 3

Conditions

HIV Infections
Herpes Genitalis
Venereal Diseases

Interventions

Male Circumcision

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

following DSMB recommandation.

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Jul 19, 2005

First Submission Date that Met QC Criteria

Jul 19, 2005

First Posted Date

Jul 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2009

Last Update Posted Date

Apr 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,274Actual

Name	Type	Description	Arm Group Labels	Other Names
Male Circumcision	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MC Centre		Orange Farm	Johannesburg		South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18682725	Background	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.
16231970	Result

ID	Term
D015658	HIV Infections
D006558	Herpes Genitalis
D012749	Sexually Transmitted Diseases
D012725	Sexual Behavior

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D046289	Body Modification, Non-Therapeutic
D003357	Cosmetic Techniques
D013812	Therapeutics
D013514	Surgical Procedures, Operative