Trial Outcomes & Findings for Addition of Raltegravir to Established Antiretroviral Suppressive Therapy (NCT NCT01245101)
NCT ID: NCT01245101
Last Updated: 2016-12-23
Results Overview
These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.
TERMINATED
PHASE4
15 participants
16 weeks
2016-12-23
Participant Flow
Please note: because of poor enrollment and inability to find the originally planned 40 patients, the study was terminated after only 15 of 20 planned patients had been enrolled into the Raltegravir Then Observation arm. No patients were enrolled into the Observation Then Raltegravir arm.
Participant milestones
| Measure |
Raltegravir Then Observation
Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
|
Observation Then Raltegravir
Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
|
|---|---|---|
|
Period 1 (Treatment)
STARTED
|
15
|
0
|
|
Period 1 (Treatment)
COMPLETED
|
13
|
0
|
|
Period 1 (Treatment)
NOT COMPLETED
|
2
|
0
|
|
Period 2 (Washout)
STARTED
|
13
|
0
|
|
Period 2 (Washout)
COMPLETED
|
12
|
0
|
|
Period 2 (Washout)
NOT COMPLETED
|
1
|
0
|
|
Period 3 (Treatment)
STARTED
|
12
|
0
|
|
Period 3 (Treatment)
COMPLETED
|
11
|
0
|
|
Period 3 (Treatment)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Raltegravir Then Observation
Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
|
Observation Then Raltegravir
Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
|
|---|---|---|
|
Period 1 (Treatment)
Withdrawal by Subject
|
2
|
0
|
|
Period 2 (Washout)
Withdrawal by Subject
|
1
|
0
|
|
Period 3 (Treatment)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
Baseline characteristics by cohort
| Measure |
Raltegravir Then Observation
n=15 Participants
Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
|
Observation Then Raltegravir
Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
—
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Gender
Female
|
11 Participants
n=5 Participants
|
—
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: 11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.
These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.
Outcome measures
| Measure |
Raltegravir Then Observation
n=11 Participants
Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
|
Observation Then Raltegravir
Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
|
|---|---|---|
|
Episomal HIV cDNA Formation
Raltegravir
|
4.581 copies/million
Standard Deviation 13.72
|
—
|
|
Episomal HIV cDNA Formation
Observation
|
0.7173 copies/million
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.
Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure.
Outcome measures
| Measure |
Raltegravir Then Observation
n=11 Participants
Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
|
Observation Then Raltegravir
Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
|
|---|---|---|
|
Markers of Immune Activation
Raltegravir
|
22.37 Percentage of activated CD8+CD38+ cells
Standard Deviation 16.73
|
—
|
|
Markers of Immune Activation
Observation
|
26.72 Percentage of activated CD8+CD38+ cells
Standard Deviation 14.93
|
—
|
Adverse Events
Raltegravir
Observation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Raltegravir
n=15 participants at risk
Raltegravir 400 mg twice a day for 16 weeks
|
Observation
Observation for 16 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place