A Study of Anal Cancer Development in HIV Infected People

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00107679
First received: April 6, 2005
Last updated: January 30, 2011
Last verified: July 2006
  Purpose

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
HIV Infections
Anus Neoplasms

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Time to high-grade anal dysplasia or anal cancer

Secondary Outcome Measures:
  • 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
  • time to cervical HPV infection with a specific strain, for types 16, 18, or 31
  • time to high-grade anal dysplasia
  • time from low-grade anal dysplasia to normal

Estimated Enrollment: 560
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107679

  Show 52 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Calvin Cohen, MD, MSc Community Research Initiative of New England
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00107679     History of Changes
Other Study ID Numbers: CPCRA 065G, SMART
Study First Received: April 6, 2005
Last Updated: January 30, 2011
Health Authority: United States: Federal Government

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Anus Neoplasms
Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
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

ClinicalTrials.gov processed this record on April 15, 2014