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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: Completed Phase 1 study of HIV Infections and Anus Neoplasms, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG Isotretinoin
- DRUG Interferon alfa-2a
Study Locations (1)
Washington
- University of Washington AIDS CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Est. Completion | 1996-07 |
| Phase | Phase 1 |
What the finished NCT00000764 record still lists
NCT00000764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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
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Where NCT00000764's enrollment target sits among peer trials
98 277th of 542 higher than 266 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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