Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01300988
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2010-12-16
Brief Title:
Effects of Treatment With Aprepitant Emend in HIV Infected Individuals 375 mg Dose
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Phase Ib Randomized Placebo Controlled Double Blind Study to Determine the Safety Viral Suppression Pharmacokinetics and Immune Modulatory Effects of Treatment With Aprepitant Emend in HIV Infected Individuals
Status:
COMPLETED
Status Verified Date:
2016-06
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 investigators in vitro data suggest that Neurokinin-1 receptor antagonists like aprepitant will decrease the expression of CCR5 an essential co-receptor in the life cycle of HIV in the surface of macrophages and lymphocytes to levels at least similar to those observed in patients heterozygous for the CCR5 32 mutation Together with a direct potential antiviral effect this could alter disease progression in patients with HIV infection
The investigators hypothesis is that aprepitant is safe tolerable and has antiviral activity in HIV infected individuals
This is randomized placebo controlled double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy
18 HIV infected males and females 18 years old who have early infection with CD4 cell counts 350 cellsmm3 Subjects will be randomized 11 to receive 375 mg of aprepitant Emend or placebo
The investigators hypothesis is that aprepitant is safe tolerable and has antiviral activity in HIV infected individuals
This is randomized placebo controlled double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy
18 HIV infected males and females 18 years old who have early infection with CD4 cell counts 350 cellsmm3 Subjects will be randomized 11 to receive 375 mg of aprepitant Emend or placebo
Detailed Description:
DESIGN
Randomized placebo controlled double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy
DURATION
42 days
SAMPLE SIZE and POPULATION
18 HIV infected males and females 18 years old who have early infection with CD4 cell counts 350 cellsmm3
REGIMEN
Subjects will be randomized 11 to receive aprepitant Emend or placebo
Arm A Aprepitant placebo Arm B Aprepitant 375 mg QD
HYPOTHESIS AND STUDY OBJECTIVES
Hypothesis Aprepitant is safe tolerable and has antiviral activity in HIV infected individuals
Primary Objectives
To assess the safety and tolerability of 375 mg aprepitant for 2 weeks To assess the response of plasma HIV-1 RNA to 375 mg of aprepitant compared with baseline
Secondary Objectives
To investigate the course and duration of antiretroviral response 375 mg of aprepitant given over a 14-day period
To evaluate the dose-response and pharmacokinetic and pharmacodynamic relationship between viral RNA change and aprepitant plasma levels
To evaluate aprepitant effects on CD4 and CD8 T-cell counts circulating SP levels natural killer cell number and function and CCR5 expression in peripheral PBMCs
To evaluate the effects of aprepitant in the viral tropism and envelope sequence of the main HIV-1 population of the participants
To assess viral drug susceptibility in conjunction with baseline coreceptor tropism phenotype and changes in coreceptor phenotype after the exposure to aprepitant
To evaluate aprepitant effects on fasting plasma glucose insulin HDL free fatty acids and triglyceride concentrations after 14 days of treatment
To provide preliminary description of any change from baseline in sleep quality anxious mood depressed mood and neurocognitive measures after 2 weeks of aprepitant therapy
Randomized placebo controlled double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy
DURATION
42 days
SAMPLE SIZE and POPULATION
18 HIV infected males and females 18 years old who have early infection with CD4 cell counts 350 cellsmm3
REGIMEN
Subjects will be randomized 11 to receive aprepitant Emend or placebo
Arm A Aprepitant placebo Arm B Aprepitant 375 mg QD
HYPOTHESIS AND STUDY OBJECTIVES
Hypothesis Aprepitant is safe tolerable and has antiviral activity in HIV infected individuals
Primary Objectives
To assess the safety and tolerability of 375 mg aprepitant for 2 weeks To assess the response of plasma HIV-1 RNA to 375 mg of aprepitant compared with baseline
Secondary Objectives
To investigate the course and duration of antiretroviral response 375 mg of aprepitant given over a 14-day period
To evaluate the dose-response and pharmacokinetic and pharmacodynamic relationship between viral RNA change and aprepitant plasma levels
To evaluate aprepitant effects on CD4 and CD8 T-cell counts circulating SP levels natural killer cell number and function and CCR5 expression in peripheral PBMCs
To evaluate the effects of aprepitant in the viral tropism and envelope sequence of the main HIV-1 population of the participants
To assess viral drug susceptibility in conjunction with baseline coreceptor tropism phenotype and changes in coreceptor phenotype after the exposure to aprepitant
To evaluate aprepitant effects on fasting plasma glucose insulin HDL free fatty acids and triglyceride concentrations after 14 days of treatment
To provide preliminary description of any change from baseline in sleep quality anxious mood depressed mood and neurocognitive measures after 2 weeks of aprepitant therapy
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 |
|---|---|---|---|
| U01MH090325 | NIH | None | httpsreporternihgovquickSearchU01MH090325 |