Effect of Male Circumcision on HIV Incidence (ANRS 1265)

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122525
• Other study ID #: ANRS 1265
• Status: Terminated
• Phase: Phase 3
• First received: July 19, 2005
• Last updated: April 29, 2009
• Start date: July 2002
• Est. completion date: July 2005

Study information

• Verified date: April 2009
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3274
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Genitalis
• HIV Infections
• Sexually Transmitted Diseases
• Venereal Diseases

Intervention

Procedure:
• Male Circumcision

Locations

Country	Name	City	State
South Africa	MC Centre	Orange Farm	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

South Africa, 

References & Publications (5)

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. — View 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 Af — View 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. Epub 2005 Oct 25. Erratum in: PL — View 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 — View 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 Infec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the protective effect of medicalized male circumcision on HIV infection		M3, M12 and M21
Secondary	Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2)		M3, M12 and M21
Secondary	Measure the protective effect on the incidence of genital ulcer disease		M3, M12 and M21

External Links

•   Sponsor web page