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NCT00107679 Clinical Trial

A Study of Anal Cancer Development in HIV Infected People

HIV Infections Clinical Trial

Official title:
Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00107679
Other study ID # CPCRA 065G
Secondary ID SMART10117
Status Completed
Phase N/A
First received April 6, 2005
Last updated April 15, 2014
Start date February 2005
Est. completion date March 2006

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

Description:

Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV, compared to people with either disease alone. Studies that have investigated the effect of highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been contradictory and inconclusive. The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined. This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. At the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. Participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. These procedures will be repeated at each annual follow-up visit. Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes, whichever comes first.

Recruitment information / eligibility
Status Completed
Enrollment 560
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Current or prior history of anal or cervical cancer

- Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States CRI-Boston CRS Boston Massachusetts
United States Eastside Family Health Ctr. CRS Denver Colorado
United States Univ. of Colorado Health Science Ctr. CRS Denver Colorado
United States Henry Ford Hosp. CRS Detroit Michigan
United States Houston AIDS Research Team CRS Houston Texas
United States Univ. of Florida, Div. of Infectious Diseases CRS Jacksonville Florida
United States LA Gay & Lesbian Community Service Ctr., Lamba Med. Group CRS Los Angeles California
United States Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) New York New York
United States Temple Univ. School of Medicine CRS Philadelphia Pennsylvania
United States Kaiser Immune Deficiency Clinic of Portland CRS Portland Oregon
United States Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS Portland Oregon
United States Castro-Mission Health Ctr. CRS San Francisco California
United States Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to high-grade anal dysplasia or anal cancer
Secondary Time to anal cancer
Secondary time to low-grade or high-grade anal dysplasia
Secondary time to anal HPV infection
Secondary time to anal HPV infection with a specific strain, for types 16, 18, or 31
Secondary time to cervical HPV infection
Secondary time to cervical HPV infection with a specific strain, for types 16, 18, or 31
Secondary time to high-grade anal dysplasia
Secondary time from low-grade anal dysplasia to normal
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