NCT00000764

Brief Summary

PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV InfectionsAnus Neoplasms

Keywords

Interferon Alfa-2aAcquired Immunodeficiency SyndromeAIDS-Related ComplexAnus NeoplasmsPapillomavirus, HumanPapovaviridae InfectionsTumor Virus InfectionsIsotretinoin

Interventions

IsotretinoinDRUG
Interferon alfa-2aDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • PCP prophylaxis (required for patients with CD4 count \< 200 cells/mm3).
  • Chemoprophylaxis for candidiasis and herpes simplex.
  • Metronidazole for up to 14 days.
  • Erythropoietin.
  • Patients must have:
  • HIV seropositivity.
  • NO active opportunistic infection requiring treatment with prohibited drugs.
  • Phase I - Current grade 1 AIN (i.e., low grade SIL) OR treated or untreated grade 2 or 3 AIN (i.e., high grade SIL).
  • Phase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days.
  • Capability of complying with study protocol.
  • NOTE:
  • The terms condyloma, grade 1 AIN, and low grade SIL are interchangeable. Grade 2 or 3 AIN is interchangeable with high grade SIL.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active medical problems for which the patient is undergoing evaluations or for which prohibited therapy is required.
  • Other active malignancies requiring systemic therapy.
  • Significant symptomatic cardiac disease.
  • NOTE:
  • Patients with malignancies being managed with local therapy (e.g., Kaposi's sarcoma, basal cell carcinoma) may enroll at the discretion of the site investigator.
  • Concurrent Medication:
  • Excluded:
  • G-CSF (filgrastim).
  • Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).
  • Corticosteroids.
  • Biologic response modifiers.
  • Cytotoxic chemotherapy.
  • Concurrent Treatment:
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

HIV InfectionsAnus NeoplasmsAcquired Immunodeficiency SyndromeAIDS-Related ComplexTumor Virus Infections

Interventions

IsotretinoinInterferon alpha-2

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Palefsky JM

    STUDY CHAIR

  • Northfelt DW

    STUDY CHAIR

  • Kaplan LD

    STUDY CHAIR

  • Critchlow C

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

July 1, 1996

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(1)