- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00075062
A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
Characteristics of Baseline Mucosal Indices of Injury and Inflammation in Men For Use in Rectal Microbicide Trials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rectal microbicides to prevent HIV transmission are currently being developed in the hope that someday they will be widely used to prevent sexually transmitted HIV. This study will examine variables in male rectal tissue; this information may be useful for future rectal microbicide safety and efficacy studies. The study will evaluate the differences in rectal tissue from HIV infected or uninfected males who either engage in anal-receptive sex (men who sleep with men, or MSM) or do not have anal-receptive sex.
The study will last approximately 7 months, with 6 weeks of follow-up. There are four groups in this study. Groups 1 and 2 will enroll HIV uninfected men; Groups 3 and 4 will enroll HIV infected men. Groups 1, 3, and 4 will comprise MSM who engage in anal-receptive sex; Group 2 will comprise men who do not. Patients will provide medical and medication history, undergo a complete physical exam, and receive HIV counseling at screening. An anoscopy (examination of the anus, anal canal, and lower rectum) and blood draw will be conducted at screening, study entry, and Weeks 2 and 4. Rectal secretions will be collected and a sigmoidoscopy (an internal examination of the rectum, distal sigmoid colon, and large bowel using a small camera) will be performed at study entry and Weeks 2 and 4.
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- David Geffen School of Medicine at UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for All Participants:
- HIV status confirmed by ELISA/Western Blot at screening
- CD4 count greater than 200 cells/mm3 at screening
- Able and willing to communicate in English
- Able and willing to provide adequate information for locator purposes
Inclusion Criteria for Men Practicing Anal-Receptive Sex (Groups 1, 3 and 4):
- Engaged in anal-receptive sex an average of at least once a week in the 2 months prior to study entry
- Agree to refrain from anal intercourse for 24 hours prior to and for one week after sigmoidoscopy
Inclusion Criteria for Men Not Practicing Anal-Receptive Sex (Group 2)
- No history of anal receptive intercourse in the 2 months prior to study entry
Inclusion Criteria for HIV Infected Men (Groups 3 and 4):
- Viral load of either greater than 10,000 copies of RNA/ml plasma or less than 50 copies RNA/ml plasma for at least 2 months prior to study entry
- Have not changed antiretroviral therapy within 6 weeks prior to study entry
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Ian McGowan, MD, PhD, University of California, Los Angeles
- Study Chair: Peter Anton, MD, University of California, Los Angeles
Publications and helpful links
General Publications
- Baron S, Poast J, Nguyen D, Cloyd MW. Practical prevention of vaginal and rectal transmission of HIV by adapting the oral defense: use of commercial lubricants. AIDS Res Hum Retroviruses. 2001 Jul 20;17(11):997-1002. doi: 10.1089/088922201300343672.
- Garg S, Tambwekar KR, Vermani K, Kandarapu R, Garg A, Waller DP, Zaneveld LJ. Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges. AIDS Patient Care STDS. 2003 Aug;17(8):377-99. doi: 10.1089/108729103322277402.
- Gross M, Buchbinder SP, Celum C, Heagerty P, Seage GR 3rd. Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team. Sex Transm Dis. 1998 Jul;25(6):296-302. doi: 10.1097/00007435-199807000-00005.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HPTN 056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | HIV SeronegativityUnited States, Puerto Rico
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
Clinical Trials on Flexible Sigmoidoscopy
-
London North West Healthcare NHS TrustUnknownFamilial Adenomatous PolyposisUnited Kingdom
-
Dr. Frank ter Borg MD PhDUMC Utrecht; Erasmus Medical Center; Academisch Medisch Centrum - Universiteit... and other collaboratorsTerminatedColorectal CancerNetherlands
-
Norwegian Department of Health and Social AffairsCompleted
-
Cancer Registry of NorwayUniversity of OsloActive, not recruitingColorectal Cancer | Colorectal AdenomasNorway
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Acquired Immunodeficiency Syndrome | RNA Virus Infections | Virus Diseases | Sexually Transmitted Diseases, Viral | Sexually Transmitted Diseases | Lentivirus Infections | Retroviridae Infections | Immunologic Deficiency Syndromes | Immune System Diseases | Slow Virus Diseases
-
Mayo ClinicTerminated
-
University of Colorado, DenverNational Center for Advancing Translational Sciences (NCATS)Active, not recruitingThe Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing SpondylitisInflammatory Bowel Diseases (IBD) | Ankylosing Spondylitis (AS)United States
-
University of California, Los AngelesCompletedHuman Immunodeficiency VirusUnited States
-
University of DundeeCompletedColorectal Cancer | Colorectal AdenomaUnited Kingdom