NCT00075062

Brief Summary

Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study is to obtain rectal samples from men to learn information that may be valuable in future clinical trials of rectal microbicides.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2004

Completed
Last Updated

August 21, 2008

Status Verified

May 1, 2006

First QC Date

December 31, 2003

Last Update Submit

August 20, 2008

Conditions

HIV InfectionsHIV Seronegativity

Interventions

Flexible SigmoidoscopyPROCEDURE
Rectal BiopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • No history of anal receptive intercourse in the 2 months prior to study entry
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • 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.

    PMID: 11485616BACKGROUND

  • 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.

    PMID: 13678540BACKGROUND

  • 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.

    PMID: 9662763BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ian McGowan, MD, PhD

    University of California, Los Angeles

    STUDY CHAIR

  • Peter Anton, MD

    University of California, Los Angeles

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 31, 2003

First Posted

January 1, 2004

Last Updated

August 21, 2008

Record last verified: 2006-05

Locations

US(1)