NCT00107679

Brief Summary

The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

13 active sites

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

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

April 6, 2005

Last Update Submit

April 15, 2014

Conditions

HIV InfectionsAnus Neoplasms

Keywords

Treatment ExperiencedHIVHPVAntiretroviral Therapy, Highly ActivePapillomavirus, Human

Outcome Measures

Primary Outcomes (1)

  • Time to high-grade anal dysplasia or anal cancer

Secondary Outcomes (8)

  • Time to anal cancer

  • time to low-grade or high-grade anal dysplasia

  • time to anal HPV infection

  • time to anal HPV infection with a specific strain, for types 16, 18, or 31

  • time to cervical HPV infection

  • +3 more secondary outcomes

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Coenrollment in the SMART study
  • Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained.
  • Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

  • Current or prior history of anal or cervical cancer
  • Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

LA Gay & Lesbian Community Service Ctr., Lamba Med. Group CRS

Los Angeles, California, 90028, United States

Location

Castro-Mission Health Ctr. CRS

San Francisco, California, 94114, United States

Location

Univ. of Colorado Health Science Ctr. CRS

Denver, Colorado, 80204-4507, United States

Location

Eastside Family Health Ctr. CRS

Denver, Colorado, 80205, United States

Location

Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

Washington D.C., District of Columbia, 20422, United States

Location

Univ. of Florida, Div. of Infectious Diseases CRS

Jacksonville, Florida, 32206, United States

Location

CRI-Boston CRS

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hosp. CRS

Detroit, Michigan, 48202, United States

Location

Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

New York, New York, 10037-1802, United States

Location

Kaiser Immune Deficiency Clinic of Portland CRS

Portland, Oregon, 97227, United States

Location

Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

Portland, Oregon, 97239, United States

Location

Temple Univ. School of Medicine CRS

Philadelphia, Pennsylvania, 19140, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Panther LA, Schlecht HP, Dezube BJ. Spectrum of human papillomavirus-related dysplasia and carcinoma of the anus in HIV-infected patients. AIDS Read. 2005 Feb;15(2):79-82, 85-6, 88, 91.

    PMID: 15712398BACKGROUND

  • Heard I, Palefsky JM, Kazatchkine MD. The impact of HIV antiviral therapy on human papillomavirus (HPV) infections and HPV-related diseases. Antivir Ther. 2004 Feb;9(1):13-22.

    PMID: 15040532BACKGROUND

  • Piketty C, Darragh TM, Da Costa M, Bruneval P, Heard I, Kazatchkine MD, Palefsky JM. High prevalence of anal human papillomavirus infection and anal cancer precursors among HIV-infected persons in the absence of anal intercourse. Ann Intern Med. 2003 Mar 18;138(6):453-9. doi: 10.7326/0003-4819-138-6-200303180-00008.

    PMID: 12639077BACKGROUND

  • Manzione CR, Nadal SR, Calore EE. [Human papillomavirus oncogenicity and grade of anal intraepithelial neoplasia in HIV positive patients]. Rev Assoc Med Bras (1992). 2004 Jul-Sep;50(3):282-5. doi: 10.1590/s0104-42302004000300035. Epub 2004 Oct 21. Portuguese.

    PMID: 15499480BACKGROUND

Related Links

MeSH Terms

Conditions

HIV InfectionsAnus Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Calvin Cohen, MD, MSc

    Community Research Initiative of New England

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2005

First Posted

April 7, 2005

Study Start

February 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

US(13)