Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00000764 · ClinicalTrials.gov registry record · Phase 1

Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

A Phase 1 study of HIV Infections and Anus Neoplasms, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
98
Enrollment target
1
Study location

NCT00000764 is a Phase 1 study of HIV Infections and Anus Neoplasms that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 98 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00000764, a Phase 1 study of HIV Infections and Anus Neoplasms, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
98 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

HIV Infections Anus Neoplasms

Interventions

  • DRUG Isotretinoin
  • DRUG Interferon alfa-2a

Study Locations (1)

Washington

  • University of Washington AIDS CRS - Seattle

Trial Details

FieldValue
Enrollment Target 98 participants
Est. Completion 1996-07
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000764

The ClinicalTrials.gov registry entry for NCT00000764 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Isotretinoin is the first listed.

NCT00000764 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT00000764 about?

NCT00000764 is a clinical study titled "Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.". 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 recurrenc...

What is the current status of trial NCT00000764?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. Estimated completion is 1996-07.

What conditions does trial NCT00000764 study?

This clinical trial studies the following conditions: HIV Infections, Anus Neoplasms.

What interventions are being tested in trial NCT00000764?

The interventions under investigation include: Isotretinoin (DRUG), Interferon alfa-2a (DRUG).

Who is sponsoring clinical trial NCT00000764?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000764 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

HIV Infections

All registered trials for this condition

Anus Neoplasms

All registered trials for this condition

Washington

All trials with a study site in Washington

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.