Effect of Male Circumcision on HIV Incidence (ANRS 1265)
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| ClinicalTrials.gov Identifier: NCT00122525 |
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Recruitment Status :
Terminated
(following DSMB recommandation.)
First Posted : July 22, 2005
Last Update Posted : April 30, 2009
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Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Herpes Genitalis Venereal Diseases | Procedure: Male Circumcision | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 3274 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration |
| Study Start Date : | July 2002 |
| Actual Study Completion Date : | July 2005 |
Primary Outcome Measures :
- Measure the protective effect of medicalized male circumcision on HIV infection [ Time Frame: M3, M12 and M21 ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122525
Locations
| South Africa | |
| MC Centre | |
| Orange Farm, Johannesburg, South Africa | |
Sponsors and Collaborators
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 |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00122525 History of Changes |
| Other Study ID Numbers: |
ANRS 1265 |
| First Posted: | July 22, 2005 Key Record Dates |
| Last Update Posted: | April 30, 2009 |
| Last Verified: | April 2009 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
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HIV Male circumcision Prevention |
HSV-2 Africa Sexual behavior |
Additional relevant MeSH terms:
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Infection HIV Infections Herpes Genitalis Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Herpes Simplex Herpesviridae Infections DNA Virus Infections Genital Diseases, Male Genital Diseases, Female |