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

July 19, 2005
April 29, 2009
July 2002
Not Provided
Measure the protective effect of medicalized male circumcision on HIV infection [ Time Frame: M3, M12 and M21 ]
Measure the protective effect of medicalized male circumcision on HIV infection at M3, M12 and M21.
Complete list of historical versions of study NCT00122525 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Effect of Male Circumcision on HIV Incidence (ANRS 1265)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Herpes Genitalis
  • Venereal Diseases
Procedure: Male Circumcision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3274
July 2005
Not Provided

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)
Male
18 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00122525
ANRS 1265
Yes
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Study Chair: Bertran Auvert, MD Hôpital Ambroise-Paré (AP-HP); Inserm U687
Principal Investigator: Adrian Puren NICD, Johannesburg, South Africa
French National Agency for Research on AIDS and Viral Hepatitis
April 2009

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