A Study of Anal Cancer Development in HIV Infected People

• ClinicalTrials.gov Identifier: NCT00107679
• Recruitment Status: Completed
• First Posted: April 7, 2005
• Last Update Posted: April 17, 2014
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

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.

Condition or disease
HIV Infections; Anus Neoplasms

Detailed 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.

Study Design

• Study Type: Observational
• Enrollment: 560 participants
• Time Perspective: Prospective
• Official Title: Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
• Study Start Date: February 2005
• Actual Primary Completion Date: March 2006
• Actual Study Completion Date: March 2006

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Time to high-grade anal dysplasia or anal cancer

Secondary Outcome Measures :

1. Time to anal cancer
2. time to low-grade or high-grade anal dysplasia
3. time to anal HPV infection
4. time to anal HPV infection with a specific strain, for types 16, 18, or 31
5. time to cervical HPV infection
6. time to cervical HPV infection with a specific strain, for types 16, 18, or 31
7. time to high-grade anal dysplasia
8. time from low-grade anal dysplasia to normal

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

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

Los Angeles, California, United States, 90028

Castro-Mission Health Ctr. CRS

San Francisco, California, United States, 94114

United States, Colorado

Univ. of Colorado Health Science Ctr. CRS

Denver, Colorado, United States, 80204-4507

Eastside Family Health Ctr. CRS

Denver, Colorado, United States, 80205

United States, District of Columbia

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

Washington, District of Columbia, United States, 20422

United States, Florida

Univ. of Florida, Div. of Infectious Diseases CRS

Jacksonville, Florida, United States, 32206

United States, Massachusetts

CRI-Boston CRS

Boston, Massachusetts, United States, 02115

United States, Michigan

Henry Ford Hosp. CRS

Detroit, Michigan, United States, 48202

United States, New York

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

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

United States, Oregon

Kaiser Immune Deficiency Clinic of Portland CRS

Portland, Oregon, United States, 97227

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

Portland, Oregon, United States, 97239

United States, Pennsylvania

Temple Univ. School of Medicine CRS

Philadelphia, Pennsylvania, United States, 19140

United States, Texas

Houston AIDS Research Team CRS

Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Calvin Cohen, MD, MSc; Community Research Initiative of New England

More Information

Additional Information:

Click here for more information on CPCRA 065 

Haga clic aquí para ver información sobre este ensayo clínico en español. 

Publications:

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.

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.

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.

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. Epub 2004 Oct 21. Portuguese.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00107679
• Other Study ID Numbers: CPCRA 065G; SMART; 10117 ( Registry Identifier: DAIDS-ES )
• First Posted: April 7, 2005
• Last Update Posted: April 17, 2014
• Last Verified: April 2014

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Treatment Experienced; HIV; HPV; Antiretroviral Therapy, Highly Active; Papillomavirus, Human

Additional relevant MeSH terms:

Anus Neoplasms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases