Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000812
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase I Placebo-Controlled Dose-Escalation Study of the Safety Tolerability and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Placebo-Controlled Dose-Escalation Study of the Safety Tolerability and Pharmacokinetics of Thalidomide in Subjects With HIV-1 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 To evaluate the safety tolerability and pharmacokinetics of daily oral thalidomide
SECONDARY To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha TNF-alpha production and the correlation between TNF-alpha inhibition and viral burden
A protein in the blood called tumor necrosis factor TNF-alpha is abnormally elevated in patients with HIV infection and may cause the body to produce more virus In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV However more information on the pharmacological and immunological aspects of thalidomide is needed
SECONDARY To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha TNF-alpha production and the correlation between TNF-alpha inhibition and viral burden
A protein in the blood called tumor necrosis factor TNF-alpha is abnormally elevated in patients with HIV infection and may cause the body to produce more virus In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV However more information on the pharmacological and immunological aspects of thalidomide is needed
Detailed Description:
A protein in the blood called tumor necrosis factor TNF-alpha is abnormally elevated in patients with HIV infection and may cause the body to produce more virus In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV However more information on the pharmacological and immunological aspects of thalidomide is needed
Patients are randomized to receive oral thalidomide or matching placebo 31 at one of three dose levels daily for 8 weeks All 12 patients at a dose level must receive treatment for at least 2 weeks before dose escalation in subsequent patients occurs The MTD is defined as the dose level immediately below that at which 3 or more of 9 patients receiving thalidomide experience dose-limiting toxicity Patients are followed for a total of 16 weeks
PER 62095 AMENDMENT Patients in cohort 1 should discontinue the previous 50 mg formulation of thalidomide once the new formulation is available Those patients may either wash out for 4 weeks and recommence the study or discontinue the study
Patients are randomized to receive oral thalidomide or matching placebo 31 at one of three dose levels daily for 8 weeks All 12 patients at a dose level must receive treatment for at least 2 weeks before dose escalation in subsequent patients occurs The MTD is defined as the dose level immediately below that at which 3 or more of 9 patients receiving thalidomide experience dose-limiting toxicity Patients are followed for a total of 16 weeks
PER 62095 AMENDMENT Patients in cohort 1 should discontinue the previous 50 mg formulation of thalidomide once the new formulation is available Those patients may either wash out for 4 weeks and recommence the study or discontinue the study
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 |
|---|---|---|---|
| 11243 | REGISTRY | DAIDS-ES | None |
| 42240 | None | None | None |