Clinical trial · Observational
A Study of Anal Cancer Development in HIV Infected People
Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
NCT00107679CI-TRIAL-00014292completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to high-grade anal dysplasia or anal cancer
Secondary outcomes (8)
- measure
- Time to anal cancer
- measure
- time to low-grade or high-grade anal dysplasia
- measure
- time to anal HPV infection
- measure
- time to anal HPV infection with a specific strain, for types 16, 18, or 31
- measure
- time to cervical HPV infection
- measure
- time to cervical HPV infection with a specific strain, for types 16, 18, or 31
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDPanther 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. PMID 15712398
- BACKGROUNDHeard 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. PMID 15040532
- BACKGROUNDPiketty 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. doi: 10.7326/0003-4819-138-6-200303180-00008. PMID 12639077
- BACKGROUNDManzione 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. doi: 10.1590/s0104-42302004000300035. Epub 2004 Oct 21. Portuguese. PMID 15499480