Clinical trial NCT00122525: Effect of Male Circumcision on HIV Incidence (ANRS 1265)
Official title: Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infections
Herpes Genitalis
Venereal Diseases
Keywords: HIV
Male circumcision
Prevention
HSV-2
Africa
Sexual behavior
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-07-22
Enrollment: 3274
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Measure the protective effect of medicalized male circumcision on HIV infection
timeFrame: M3, M12 and M21
Secondary outcomes:
measure: Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2)
timeFrame: M3, M12 and M21
measure: Measure the protective effect on the incidence of genital ulcer disease
timeFrame: M3, M12 and M21
Other outcomes:
Locations:
city: Orange Farm
country: South Africa
facility: MC Centre
state: Johannesburg
Study officials:
affiliation: Hôpital Ambroise-Paré (AP-HP); Inserm U687
name: Bertran Auvert, MD
role: STUDY_CHAIR
affiliation: NICD, Johannesburg, South Africa
name: Adrian Puren
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
citation: Sobngwi-Tambekou J, Taljaard D, Nieuwoudt M, Lissouba P, Puren A, Auvert B. Male circumcision and Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis: observations after a randomised controlled trial for HIV prevention. Sex Transm Infect. 2009 Apr;85(2):116-20. doi: 10.1136/sti.2008.032334. Epub 2008 Dec 15.
citation: Sobngwi-Tambekou J, Taljaard D, Lissouba P, Zarca K, Puren A, Lagarde E, Auvert B. Effect of HSV-2 serostatus on acquisition of HIV by young men: results of a longitudinal study in Orange Farm, South Africa. J Infect Dis. 2009 Apr 1;199(7):958-64. doi: 10.1086/597208.
citation: Auvert B, Sobngwi-Tambekou J, Cutler E, Nieuwoudt M, Lissouba P, Puren A, Taljaard D. Effect of male circumcision on the prevalence of high-risk human papillomavirus in young men: results of a randomized controlled trial conducted in Orange Farm, South Africa. J Infect Dis. 2009 Jan 1;199(1):14-9. doi: 10.1086/595566.
citation: Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, Taljaard D, Puren A, Agot K, Serwadda D, Parker CB, Wawer MJ, Bailey RC. Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS. 2009 Jul 31;23(12):1557-64. doi: 10.1097/QAD.0b013e32832afe95.