Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122525
Status:
TERMINATED
Last Update Posted:
2009-04-30
First Post:
2005-07-19
Brief Title:
Effect of Male Circumcision on HIV Incidence ANRS 1265
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Effect of Safe Male Circumcision on Incidence of Infection by HIV HSV-2 and of Genital Ulceration
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
following DSMB recommandation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 M0 to M 21 Randomization and medicalized circumcision will be performed at M0 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 M3 3 months after medicalized circumcision Incidences of HIV HSV-2 infections and genital ulcer disease will be compared from M3 to M21 between the intervention group and the control group An intermediate analysis will take place at M 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None