A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials

Exclusion Criteria

• •For HIV infected patients, 3 or more HSV-2 (herpes) outbreaks in the 12 months prior to screening or 1 or more HSV-2 outbreaks in the 6 months prior to screening
• •Active, serious infections (other than HIV) requiring parenteral antibiotic therapy within 15 days prior to screening
• •Inflammatory bowel disease (ulcerative colitis or Crohn's disease) or rectal cancer
• •Rectal surgery, including fistulectomy
• •Diagnosed bleeding disorder, including hemophilia, thrombocytopenia, impaired blood clotting, or current use of anticoagulants that, in the opinion of the investigator, would make participation in the study unsafe or complicate interpretation of study outcome data
• •Prosthetic heart valve or diagnosis of valve abnormality
• •Hemorrhoid surgery in the 6 months prior to screening
• •Bleeding hemorrhoids at screening or in the 6 weeks prior to study entry
• •Anal fistulae in the 6 weeks prior to study entry
• •Active diarrheal disease (greater than 3 times a day) or bleeding disorder
• •Rectal cultures positive for chlamydia or gonorrhea at screening or within 1 month prior to study entry
• •Unprotected anal intercourse in the 3 months prior to study entry
• •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with study requirements
• •Enrolled in any other clinical trial for the duration of their participation in HPTN 056