Clinical trial · Observational
Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials
- 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)
RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment. PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aids-related Malignancies | AIDS-Related Malignant Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Precancerous Condition | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colposcopic biopsy | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| histological technique | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Specimen Collection
- description
- Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
- interventionNames
- Genetic: polymerase chain reaction
- Other: cytology specimen collection procedure
- Other: histological technique
- Procedure: colposcopic biopsy
Primary outcomes (5)
- measure
- Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
- timeFrame
- Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
- measure
- Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials
- timeFrame
- Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Serologic documentation of HIV infection by any FDA-approved tests * Enrolled in an AIDS Malignancy Clinical Trials Consortium (AMC) clinical trial of any new or existing pharmacotherapeutic agent for treatment of disease other than human papillomavirus (HPV)-associated neoplasia * AMC study must have an accrual target of \> 15 patients PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100% * Life expectancy ≥ 3 months * Not pregnant or nursing * Patients receiving myelosuppressive therapy must meet the following criteria: * ANC \> 1,000/μL * Platelet count \> 50,000/μL * Evaluated before treatment or completely recovered from their nadir * Able to understand and willing to sign a written informed consent document * No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available