Effect of Male Circumcision on HIV Incidence (ANRS 1265)

April 29, 2009 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Johannesburg
      • Orange Farm, Johannesburg, South Africa
        • MC Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2)
Time Frame: M3, M12 and M21
M3, M12 and M21
Measure the protective effect on the incidence of genital ulcer disease
Time Frame: M3, M12 and M21
M3, M12 and M21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2009

Last Update Submitted That Met QC Criteria

April 29, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 1265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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