Trial Outcomes & Findings for Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects (NCT NCT00654147)
NCT ID: NCT00654147
Last Updated: 2015-08-03
Results Overview
time to confirmed viologic failure at 24 weeks (up to 48 weeks)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
weeks
Results posted on
2015-08-03
Participant Flow
Patients were randomly assigned to receive one of two regimens Raltegravir (Isentress, Merck \& Company) 400 mg twice daily with either Lopinavir/ritonavir (Kaletra, Abbott Laboratories) 200 mg/100 mg twice daily or with emtricitabine/tenofovir (Truvada, Gilead Sciences) 200 mg/100 mg twice daily.
Participants with acute or recent HIV-1 infection, major resistance-associated mutation on any genotype performed at any time prior to study entry, serious illness requiring systemic treatment and/or hospitalization within 7 days of study entry, HBsAg positivity, acute hepatitis of any etiology, clinically significant liver disease were excluded
Participant milestones
| Measure |
Raltegravir & Lopinavir/Ritonavir
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Baseline characteristics by cohort
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet every 12 hours for 48 \& Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours for 48 weeks \& emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
Total
n=44 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
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeksPopulation: descriptive
time to confirmed viologic failure at 24 weeks (up to 48 weeks)
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Time to Confirmed Virologic Failure
|
28 weeks
Interval 25.0 to 56.0
|
29 weeks
Interval 21.0 to 56.0
|
PRIMARY outcome
Timeframe: week 24 (up to 48 weeks)time to virologic failure at week 24 (up to 48 weeks)
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Time to Virologic Failure
|
3.2296 weeks
Standard Deviation 0.1596
|
2.9952 weeks
Standard Deviation 0.1812
|
SECONDARY outcome
Timeframe: 48 weeksgrade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Study Medication Toxicity-related Discontinuation .
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: from date of treatment start to first week documented viral suppressiontime to viral suppression noted as week on study treatment to attain HIV-1 RNA \< 200 copies/ml
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Weeks to HIV-1 RNA <200 Copies/ml
week to <200 Copies/ml
|
28 week to viral supresssion
Interval 14.0 to 56.0
|
28 week to viral supresssion
Interval 14.0 to 33.0
|
|
Weeks to HIV-1 RNA <200 Copies/ml
week to <50 Copies/ml
|
56 week to viral supresssion
Interval 28.0 to 108.0
|
56 week to viral supresssion
Interval 28.0 to 57.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 and 24Population: Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.
mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Change From Baseline CD4+ and CD8+ Cell Counts
week 16 CD4 cells
|
516.34 cells/mm3
Standard Error 76.52
|
452.11 cells/mm3
Standard Error 92.48
|
|
Change From Baseline CD4+ and CD8+ Cell Counts
week 24 CD4 cells
|
521.31 cells/mm3
Standard Error 76.52
|
482.36 cells/mm3
Standard Error 93.32
|
SECONDARY outcome
Timeframe: date started study treatment to first week documented change study treatment up to week 48study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment
Outcome measures
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 Participants
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 Participants
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Study Medication Tolerability
|
1 participants
|
0 participants
|
Adverse Events
Raltegravir & Lopinavir/Ritonavir
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Raltegravir & Emtricitabine/Tenofovir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 participants at risk
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 participants at risk
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Hepatobiliary disorders
Total bilirubin
|
9.5%
2/21 • Number of events 2 • 1 year
|
0.00%
0/23 • 1 year
|
|
Endocrine disorders
trigylcerides
|
9.5%
2/21 • Number of events 3 • 1 year
|
0.00%
0/23 • 1 year
|
Other adverse events
| Measure |
Raltegravir & Lopinavir/Ritonavir
n=21 participants at risk
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
Raltegravir & Emtricitabine/Tenofovir
n=23 participants at risk
Raltegravir 400 mg tablet every 12 hours \& emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
|---|---|---|
|
Gastrointestinal disorders
nausea and vomiting
|
4.8%
1/21 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
4.8%
1/21 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
Additional Information
Director AIDS Clinical Research Unit
University of Miami School of Medicine
Phone: 305-243-3838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place