Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000764
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
In the Phase I portion of the study 20 patients per site each receive isotretinoin in escalating doses If a patient experiences grade 2 or worse toxicity or grade 3 or worse hypertriglyceridemia dose is reduced to the previously tolerated dose for the remainder of the 6 week period Patients are then reassessed for anal neoplasia those with no progression and no grade 2 or worse toxicity receive an additional 6 weeks of isotretinoin in combination with interferon alfa-2a For Phase II of the study a separate group of patients who have undergone ablative therapy are randomized to one of three arms 26 patientsarm isotretinoin alone at the dose tolerated by at least 60 percent of patients in Phase I isotretinoin plus interferon alfa-2a or observation only Treatment continues for 48 weeks
In the Phase I portion of the study 20 patients per site each receive isotretinoin in escalating doses If a patient experiences grade 2 or worse toxicity or grade 3 or worse hypertriglyceridemia dose is reduced to the previously tolerated dose for the remainder of the 6 week period Patients are then reassessed for anal neoplasia those with no progression and no grade 2 or worse toxicity receive an additional 6 weeks of isotretinoin in combination with interferon alfa-2a For Phase II of the study a separate group of patients who have undergone ablative therapy are randomized to one of three arms 26 patientsarm isotretinoin alone at the dose tolerated by at least 60 percent of patients in Phase I isotretinoin plus interferon alfa-2a or observation only Treatment continues for 48 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11193 | REGISTRY | DAIDS ES Registry Number | None |