Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Male Circumcision: HIV, STD and Behavioral Effects in Men, Women and the Community
Brief Summary: This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.

Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (\~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007.

The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: valacyclovir | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: valacyclovir; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
B: Arm Label: Arm 1 Male circumcision; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Male circumcision | Arm Label: Arm 2; Type: NO_INTERVENTION; Interventions: Procedure: Male circumcision | Intervention Type: PROCEDURE; Name: Male circumcision; Assigned to Arm(s): Arm 1 Male circumcision, Arm 2
C: Arm Label: Acyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Generic acyclovir | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Generic acyclovir; Assigned to Arm(s): Acyclovir | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: valacyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Valacyclovir | Arm Label: high dose valacyclovir; Type: EXPERIMENTAL; Interventions: Drug: valacyclovir | Intervention Type: DRUG; Name: valacyclovir; Assigned to Arm(s): high dose valacyclovir | Intervention Type: DRUG; Name: Valacyclovir; Assigned to Arm(s): valacyclovir

Answer: B