Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099671
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-12-17
Brief Title:
Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
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 Randomized Placebo-Controlled Double-Blind Study Evaluating the Safety of Subcutaneous Single Dose Interleukin-7 in HIV-1-Infected Subjects Who Are Receiving Antiretroviral Treatment
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:
The purpose of this study is to determine the safety of a single under-the-skin dose of interleukin-7 IL-7 in HIV infected people currently taking anti-HIV drugs
Detailed Description:
CD4 count is the best predictor of HIV disease progression IL-7 plays an important role in immune system function especially in the development of T cells including CD4 cells IL-7 may improve HIV-specific immune responses by increasing the number of CD4 cells and boosting immune response This study will evaluate the safety of a single IL-7 dose given under the skin in HIV infected patients who are currently on potent antiretroviral therapy ART
This study will last 13 weeks Participants will be stratified into two groups by viral load Stratum 1 participants will have viral loads of less than 50 copiesml and Stratum 2 participants will have viral loads between 50 and 50000 copiesml Participants will receive one dose of either IL-7 or placebo at study entry Five different dosing levels of IL-7 will be tested sequentially in both strata Dose escalation will occur independently in each stratum and enrollment in a stratum will end when the maximum-tolerated dose is reached As of 102306 due to adverse events associated with the 60 mcgkg dose level all participants will receive up to the 30 mcgkg dose level with no further dose escalation New participants will enroll in Stratum 2 only
There will be 9 study visits medical and medication history a physical exam lymph node and spleen assessment and blood collection will occur at most visits Participants will undergo an electrocardiogram at study entry and on Day 1 and a spleen ultrasound at Week 3 Urine collection will occur on Day 4 and at Weeks 2 and 3
This study will last 13 weeks Participants will be stratified into two groups by viral load Stratum 1 participants will have viral loads of less than 50 copiesml and Stratum 2 participants will have viral loads between 50 and 50000 copiesml Participants will receive one dose of either IL-7 or placebo at study entry Five different dosing levels of IL-7 will be tested sequentially in both strata Dose escalation will occur independently in each stratum and enrollment in a stratum will end when the maximum-tolerated dose is reached As of 102306 due to adverse events associated with the 60 mcgkg dose level all participants will receive up to the 30 mcgkg dose level with no further dose escalation New participants will enroll in Stratum 2 only
There will be 9 study visits medical and medication history a physical exam lymph node and spleen assessment and blood collection will occur at most visits Participants will undergo an electrocardiogram at study entry and on Day 1 and a spleen ultrasound at Week 3 Urine collection will occur on Day 4 and at Weeks 2 and 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5214 | Registry Identifier | DAIDS ES Registry Number | None |
| 10022 | REGISTRY | None | None |