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A Study of Anal Cancer Development in HIV Infected People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107679
Recruitment Status : Completed
First Posted : April 7, 2005
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

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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

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00107679

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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)
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Study Chair: Calvin Cohen, MD, MSc Community Research Initiative of New England
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00107679    
Other Study ID Numbers: CPCRA 065G
10117 ( Registry Identifier: DAIDS-ES )
First Posted: April 7, 2005    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Antiretroviral Therapy, Highly Active
Papillomavirus, Human
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases