A Study of Anal Cancer Development in HIV Infected People
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| ClinicalTrials.gov Identifier: NCT00107679 |
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Recruitment Status :
Completed
First Posted : April 7, 2005
Last Update Posted : April 17, 2014
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| Condition or disease |
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| HIV Infections Anus Neoplasms |
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 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 |
- Time to high-grade anal dysplasia or anal cancer
- 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
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.
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT00107679
| 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 | |
| Study Chair: | Calvin Cohen, MD, MSc | Community Research Initiative of New England |
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00107679 History of Changes |
| Other Study ID Numbers: |
CPCRA 065G SMART 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):
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Treatment Experienced HIV HPV Antiretroviral Therapy, Highly Active Papillomavirus, Human |
Additional relevant MeSH terms:
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HIV Infections Anus Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases 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 |