Trial Outcomes & Findings for Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients (NCT NCT00672932)
NCT ID: NCT00672932
Last Updated: 2013-07-05
Results Overview
CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.
COMPLETED
NA
18 participants
three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)
2013-07-05
Participant Flow
Participant milestones
| Measure |
Raltegravir Group
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
|
No Augmented Treatment Then Optional Rollover
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
Completed Initial 12-week Assignment
|
9
|
9
|
|
Overall Study
Provided Analyzable Blood and CSF Sample
|
8
|
9
|
|
Overall Study
Rolled Over to Raltegravir
|
0
|
6
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients
Baseline characteristics by cohort
| Measure |
Raltegravir Group
n=9 Participants
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
|
No Augmented Treatment
n=9 Participants
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
52.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)Population: One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.
CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.
Outcome measures
| Measure |
Raltegravir Group
n=14 Participants
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
|
No Augmented Treatment
n=9 Participants
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
|
|---|---|---|
|
Change in CSF Concentrations of Neopterin After 12 Weeks
|
0.1 nmol/L
Standard Deviation 0.3
|
0.3 nmol/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)Population: One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.
Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.
Outcome measures
| Measure |
Raltegravir Group
n=14 Participants
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
|
No Augmented Treatment
n=9 Participants
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
|
|---|---|---|
|
Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR
|
0.51 percentage of cells
Standard Deviation 1.03
|
0.66 percentage of cells
Standard Deviation 1.20
|
Adverse Events
Raltegravir Group
No Augmented Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place