Trial Outcomes & Findings for A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen (NCT NCT00749580)
NCT ID: NCT00749580
Last Updated: 2014-12-17
Results Overview
Number of patients with virologic suppression\< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
at 24weeks for each patient
Results posted on
2014-12-17
Participant Flow
Participants were recruited from the HIllsborough County Health Department, and Tampa Care Clinic, Tampa, Florida.
Per the inclusion and exclusion criteria
Participant milestones
| Measure |
Switched
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
|
Controlled
Group 2 Continue the same regimen without change
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Switched
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
|
Controlled
Group 2 Continue the same regimen without change
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen
Baseline characteristics by cohort
| Measure |
1: Boosted PI+RAL
n=21 Participants
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
|
2: Boosted PI+NRTIs
n=25 Participants
Group 2 Continue the same regimen without change
|
Total
n=46 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
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 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
|
45 years
STANDARD_DEVIATION 9 • n=5 Participants
|
49 years
STANDARD_DEVIATION 8 • n=7 Participants
|
47 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24weeks for each patientNumber of patients with virologic suppression\< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.
Outcome measures
| Measure |
Boosted PI+RAL
n=21 Participants
Switch NRTI backbone to RAL
|
Boosted PI+NRTIs
n=19 Participants
Continue the same regimen without change
|
|---|---|---|
|
Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen
|
18 participants
|
18 participants
|
SECONDARY outcome
Timeframe: at 48 weeks for each patientOutcome measures
| Measure |
Boosted PI+RAL
n=17 Participants
Switch NRTI backbone to RAL
|
Boosted PI+NRTIs
n=17 Participants
Continue the same regimen without change
|
|---|---|---|
|
Virologic Suppression of < 75 Copies/ml at 48 Weeks
|
14 participants
|
16 participants
|
Adverse Events
Switched
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Controlled
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Switched
n=21 participants at risk
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
|
Controlled
n=25 participants at risk
Group 2 Continue the same regimen without change
|
|---|---|---|
|
Renal and urinary disorders
Faconi syndrome
|
0.00%
0/21
|
4.0%
1/25
|
Other adverse events
| Measure |
Switched
n=21 participants at risk
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
|
Controlled
n=25 participants at risk
Group 2 Continue the same regimen without change
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erthema
|
4.8%
1/21
|
4.0%
1/25
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Pruritus( local, not drug rash))
|
9.5%
2/21
|
4.0%
1/25
|
|
General disorders
fatigue
|
4.8%
1/21
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
swelling
|
9.5%
2/21
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
rash
|
4.8%
1/21
|
4.0%
1/25
|
|
Nervous system disorders
Instability
|
4.8%
1/21
|
0.00%
0/25
|
|
General disorders
loss appetitie
|
0.00%
0/21
|
8.0%
2/25
|
|
Nervous system disorders
Headache
|
28.6%
6/21
|
4.0%
1/25
|
|
Psychiatric disorders
Depression
|
4.8%
1/21
|
0.00%
0/25
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21
|
4.0%
1/25
|
|
General disorders
dry mouth
|
9.5%
2/21
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
4.8%
1/21
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21
|
4.0%
1/25
|
|
Immune system disorders
Worsening seasonal allergy
|
0.00%
0/21
|
4.0%
1/25
|
|
Infections and infestations
sore throat
|
4.8%
1/21
|
0.00%
0/25
|
|
General disorders
weight gain
|
4.8%
1/21
|
0.00%
0/25
|
|
Gastrointestinal disorders
vomiting
|
4.8%
1/21
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21
|
4.0%
1/25
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
1/21
|
0.00%
0/25
|
|
Gastrointestinal disorders
flatulence
|
4.8%
1/21
|
0.00%
0/25
|
|
General disorders
Increase appetite
|
4.8%
1/21
|
0.00%
0/25
|
|
General disorders
Dizziness
|
4.8%
1/21
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
3/21
|
4.0%
1/25
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/21
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.8%
1/21
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.8%
1/21
|
0.00%
0/25
|
|
Surgical and medical procedures
Condyloma removal
|
4.8%
1/21
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma insitu
|
4.8%
1/21
|
0.00%
0/25
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/21
|
4.0%
1/25
|
|
Gastrointestinal disorders
Abnormal liver function
|
4.8%
1/21
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
4.8%
1/21
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place