laboratory biomarker analysis for Human Papillomavirus Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Human Papillomavirus Infections+11 More
laboratory biomarker analysis - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two different ways to prevent anal cancer in patients with HIV and high-grade squamous intraepithelial lesions (HSIL). The first way is called topical or ablative treatment. The second way is called active monitoring. The trial is almost finished, and the data shows that the first way is better at preventing anal cancer. So all the people in the trial are being offered the first way of treatment.

Eligible Conditions
  • Human Papillomavirus Infections
  • HSIL, High Grade Squamous Intraepithelial Lesions
  • Cancer, Anal
  • HIV

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Human Papillomavirus Infections

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Day 112
ANCHOR Study Health-Related Symptom Index (A-HRSI) scale responsiveness (sensitivity to change)
Week 4
Quality of life assessment measured by the A-HRSI (validated tool)
Week 16
Scale responsiveness of A-HRSI symptom index (completed February 2020)
Year 5
Time to anal cancer
Up to 5 years
Quality of life assessed using the Functional Assessment of Incontinence Therapy - Fecal (FAIT-F) questionnaire
Year 5
Behavioral risk factors for HSIL progression to cancer
Host and viral biomarkers of progression from HSIL to cancer
Malignant Neoplasms
Incidence of adverse events for each treatment
Viral factors in HSIL progression to cancer

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Human Papillomavirus Infections

Trial Design

3 Treatment Groups

Arm II (active monitoring) (closed since SEP2021)
1 of 3
Arm II (active monitoring)
1 of 3
Arm I (treatment)
1 of 3
Active Control
Experimental Treatment

4459 Total Participants · 3 Treatment Groups

Primary Treatment: laboratory biomarker analysis · No Placebo Group · Phase 3

Arm I (treatment)Experimental Group · 7 Interventions: fluorouracil, laboratory biomarker analysis, infrared photocoagulation therapy, thermal ablation therapy, laser therapy, clinical observation, imiquimod · Intervention Types: Drug, Other, Device, Device, Device, Other, Drug
Arm II (active monitoring) (closed since SEP2021)ActiveComparator Group · 2 Interventions: laboratory biomarker analysis, clinical observation · Intervention Types: Other, Other
Arm II (active monitoring)ActiveComparator Group · 2 Interventions: laboratory biomarker analysis, clinical observation · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
infrared photocoagulation therapy
2011
Completed Phase 3
~140
laser therapy
2008
Completed Phase 2
~400
Imiquimod
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,262 Previous Clinical Trials
11,465,645 Total Patients Enrolled
AIDS Malignancy ConsortiumLead Sponsor
60 Previous Clinical Trials
4,996 Total Patients Enrolled
2 Trials studying Human Papillomavirus Infections
522 Patients Enrolled for Human Papillomavirus Infections
University of ArkansasOTHER
459 Previous Clinical Trials
142,051 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
135 Previous Clinical Trials
4,635,055 Total Patients Enrolled
University of ArizonaOTHER
456 Previous Clinical Trials
151,695 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,294,034 Total Patients Enrolled
23 Trials studying Human Papillomavirus Infections
49,228 Patients Enrolled for Human Papillomavirus Infections
Joel Palefsky, MDPrincipal InvestigatorAIDS Malignancy Consortium
8 Previous Clinical Trials
3,812 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an absolute neutrophil count of at least 750/mm^3.
You have hemoglobin > 9.0 g/dL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Grady Health System100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%