Trial · NCT02135419

Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

NCT02135419, Phase 3, Completed, AIDS Malignancy Consortium; results first posted 2022-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions. Trials, record NCT02135419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135419

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
NCT number: NCT02135419
Status: Completed
Phases: Phase 3
Enrollment: 4,446 participants, actual
Lead sponsor: AIDS Malignancy Consortium
Conditions: Anal Cancer, High-grade Squamous Intraepithelial Lesion, HIV Infection, Human Papilloma Virus Infection
Interventions: imiquimod, fluorouracil, infrared photocoagulation therapy, thermal ablation therapy, laser therapy, clinical observation, laboratory biomarker analysis
First posted: 2014-05-12
Last updated: 2024-07-26
Results first posted: 2022-12-02

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Anal Cancer Incidence	Time from randomization to diagnosis of anal cancer, assessed up to 5 years post randomization	Anal cancer incidence is calculated as the number of anal cancer cases detected per 100,000 person years
Secondary	Incidence of Adverse Events for Each Treatment	Up to 5 years after randomization	Participants who had at least one adverse event (serious or non-serious)
Secondary	Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization	4 weeks post randomization	The physical symptom score is made up of the sum of responses to whether or not the participant had any of the 9 physical symptoms: anal pain, pain other than anal pain, pain during bowel movements, constipation, bleeding from anus, itching in/around the anus, discharge (wetness) in anal area, burning sensations in the anal area, and urgency for bowel movements. Responses are 0- not at all, 1-a little bit, 2-somewhat, 3-quite a bit, 4-very much. Thus physical symptom score ranges from 0 to 36.
Other	Viral Factors in HSIL Progression to Cancer	Up to 5 years after randomization	Descriptive statistics will be used to describe the integration locus of HPV In the invasive cancers and whether they differ from those of the overlying HSIL. Descriptive statistics will also be used to determine if the loci differ in HSIL that have progressed and concurrent HSIL biopsies that did not progress. In each case only tissues that contain HPV 16 will be analyzed.
Other	Host Factors in HSIL Progression to Cancer	Up to 5 years after randomization	Linear models will be fitted for each gene. Moderated t-statistics, fold-change and the associated p values will be calculated for each gene. Since thousands of genes will be tested, false discovery rate (FDR)-adjusted values will be calculated using the Benjamini-Hochberg method. FDR values indicate the expected fraction of falsely declared differentially expressed (DE) genes among the total set of declared DE genes, i.e. FDR = 0.15 would indicate that 15% of the declared DE genes were expected to be false due to experimental noise instead of actual differential expression.
Other	Host and Viral Biomarkers of Progression From HSIL to Cancer	Up to 5 years after randomization	Biomarkers that are correlated with progression from anal HSIL to anal cancer
Other	Behavioral Risk Factors for HSIL Progression to Cancer	Up to 5 years after randomization	For each risk factor of interest, Fisher's exact test or Pearson's chi-square test will be used to determine if there is an association. Factors associated with invasive anal cancer at the 0.10 significance level will be incorporated into a logistic regression model to determine if they are independently associated with invasive anal cancer. Cox regression analyses will also be used to evaluate the association between risk factors and time to diagnosis of invasive anal cancer.
Other	ANCHOR Study Health-Related Symptom Index (A-HRSI) Scale Responsiveness (Sensitivity to Change)	A-HRSI and self-reported Patient Global Impression of Change (PGIC) scale and ECOG Performance Status (ECOG PS) item were administered at time of enrollment (T1) up until time of trial randomization (T2), and 71-112 days post-randomization (T3).	Participants at follow-up timepoints were categorized into two sets of three groups based on PGIC and ECOG PS responses ("worse," "no change," "better"), with the primary responsiveness analysis using these three groups in a one-way analysis of variance (ANOVA).
Other	Quality of Life Assessment Measured by the A-HRSI (Validated Tool)	A-HRSI completion occurred at 3 time points: Pre-randomization (T1), within 2-7 days (T2) and at 4 weeks of treatment/randomization (T3).	A-HRSI physical symptoms and physical impacts subscale change scores (T3 minus T2) using an analysis of covariance adjusting for the covariate baseline (T1) subscale to test for differences between arms at a one-sided 0.025 significance level with approximately 90% power.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Anal Cancer Incidence	Time from randomization to diagnosis of anal cancer, assessed up to 5 years post randomization	Participants who were randomized and received the assigned intervention	cases per 100,000 person years	NUMBER
SECONDARY	Incidence of Adverse Events for Each Treatment	Up to 5 years after randomization	Participants who received assigned intervention	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization	4 weeks post randomization	Participants who were randomized on the ANCHOR study and for whom physical symptom scores were obtained at baseline and 4 weeks post-randomization.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Viral Factors in HSIL Progression to Cancer	Up to 5 years after randomization
OTHER_PRE_SPECIFIED	Host Factors in HSIL Progression to Cancer	Up to 5 years after randomization
OTHER_PRE_SPECIFIED	Host and Viral Biomarkers of Progression From HSIL to Cancer	Up to 5 years after randomization
OTHER_PRE_SPECIFIED	Behavioral Risk Factors for HSIL Progression to Cancer	Up to 5 years after randomization
OTHER_PRE_SPECIFIED	ANCHOR Study Health-Related Symptom Index (A-HRSI) Scale Responsiveness (Sensitivity to Change)	A-HRSI and self-reported Patient Global Impression of Change (PGIC) scale and ECOG Performance Status (ECOG PS) item were administered at time of enrollment (T1) up until time of trial randomization (T2), and 71-112 days post-randomization (T3).
OTHER_PRE_SPECIFIED	Quality of Life Assessment Measured by the A-HRSI (Validated Tool)	A-HRSI completion occurred at 3 time points: Pre-randomization (T1), within 2-7 days (T2) and at 4 weeks of treatment/randomization (T3).

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Anal Cancer Incidence	Arm I (Treatment)	173	95% Confidence Interval 90 to 332	cases per 100,000 person years
Anal Cancer Incidence	Arm II (Active Monitoring) (Closed Since SEP2021)	402	95% Confidence Interval 262 to 616	cases per 100,000 person years
Incidence of Adverse Events for Each Treatment	Arm I (Treatment)	416		Participants
Incidence of Adverse Events for Each Treatment	Arm II (Active Monitoring) (Closed Since SEP2021)	429		Participants
Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization	Arm I (Treatment)	-2.22	Standard Deviation 4.69	score on a scale
Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization	Arm II (Active Monitoring) (Closed Since SEP2021)	-0.08	Standard Deviation 3.31	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Treatment)	2,227
Overall Study	STARTED	Arm II (Active Monitoring) (Closed Since SEP2021)	2,219
Overall Study	COMPLETED	Arm I (Treatment)	2,071
Overall Study	COMPLETED	Arm II (Active Monitoring) (Closed Since SEP2021)	2,080
Overall Study	NOT COMPLETED	Arm I (Treatment)	156
Overall Study	NOT COMPLETED	Arm II (Active Monitoring) (Closed Since SEP2021)	139

Source ClinicalTrials.gov

Adverse events228

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Infections and Infestations, other	Infections and infestations	Arm I (Treatment)	40	2,227
other	Infections and Infestations, other	Infections and infestations	Arm II (Active Monitoring) (Closed Since SEP2021)	36	2,219
other	Cardiac Disorders, Other	Cardiac disorders	Arm I (Treatment)	1	2,227
other	Cardiac Disorders, Other	Cardiac disorders	Arm II (Active Monitoring) (Closed Since SEP2021)	1	2,219
other	Chest pain - cardiac	Cardiac disorders	Arm I (Treatment)	1	2,227
other	Chest pain - cardiac	Cardiac disorders	Arm II (Active Monitoring) (Closed Since SEP2021)	1	2,219
other	Cataract	Eye disorders	Arm I (Treatment)	0	2,227
other	Cataract	Eye disorders	Arm II (Active Monitoring) (Closed Since SEP2021)	1	2,219
other	Abdominal pain	Gastrointestinal disorders	Arm I (Treatment)	0	2,227
other	Abdominal pain	Gastrointestinal disorders	Arm II (Active Monitoring) (Closed Since SEP2021)	1	2,219

1 to 10 of 228Source ClinicalTrials.gov

See all 228 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Treatment)	55	2,227
Total, all-cause mortality	Arm II (Active Monitoring) (Closed Since SEP2021)	48	2,219
Total, other adverse events	Arm I (Treatment)	82	2,227
Total, other adverse events	Arm II (Active Monitoring) (Closed Since SEP2021)	60	2,219
Total, serious adverse events	Arm I (Treatment)	370	2,227
Total, serious adverse events	Arm II (Active Monitoring) (Closed Since SEP2021)	375	2,219

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33594934	DERIVED	PubMed
35017115	BACKGROUND	PubMed
35416975	DERIVED	PubMed
35704479	RESULT	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
UM1CA121947	Consortium for Advancing Management and Prevention of Cancer in People with HIV	SPARANO, JOSEPH A.	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	NATIONAL CANCER INSTITUTE	2015 to 2025	NIH RePORTER
U01CA121947	AIDS Malignancy Clinical Trials Consortium (AMC)	MITSUYASU, RONALD T.	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL CANCER INSTITUTE	2006 to 2014	NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Treatment) vs Arm II (Active Monitoring) (Closed Since SEP2021): Incidence of Adverse Events for Each Treatment	Trial comparisons
Arm I (Treatment) vs Arm II (Active Monitoring) (Closed Since SEP2021): deaths from any cause	Trial comparisons
Arm I (Treatment) vs Arm II (Active Monitoring) (Closed Since SEP2021): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02135419

GET https://conductscience.org/api/trials/v1/NCT02135419/events?page=2

API reference For AI assistants