Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment). (NCT NCT00534352)
NCT ID: NCT00534352
Last Updated: 2015-04-16
Results Overview
At visit Days 14 \& 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 weeks
Results posted on
2015-04-16
Participant Flow
The 42-day open-label main treatment phase of this trial was conducted from 10 December 2007 to 27 May 2008. Four investigators from the US participated in this multicenter trial. A total of 35 subjects were screened and of these, 23 subjects entered the trial and started the first treatment phase
Participant milestones
| Measure |
TDF/FTC +/- TMC125 +/- DRV/Rtv
In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC.
|
|---|---|
|
Treatment A: TMC125 + TDF/FTC
STARTED
|
23
|
|
Treatment A: TMC125 + TDF/FTC
COMPLETED
|
21
|
|
Treatment A: TMC125 + TDF/FTC
NOT COMPLETED
|
2
|
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
STARTED
|
21
|
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
COMPLETED
|
21
|
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
NOT COMPLETED
|
0
|
|
Treatment C: DRV/Rtv + TDF/FTC
STARTED
|
21
|
|
Treatment C: DRV/Rtv + TDF/FTC
COMPLETED
|
20
|
|
Treatment C: DRV/Rtv + TDF/FTC
NOT COMPLETED
|
1
|
|
Optional Extension: DRV/Rtv + TDF/FTC
STARTED
|
18
|
|
Optional Extension: DRV/Rtv + TDF/FTC
COMPLETED
|
14
|
|
Optional Extension: DRV/Rtv + TDF/FTC
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
TDF/FTC +/- TMC125 +/- DRV/Rtv
In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC.
|
|---|---|
|
Treatment A: TMC125 + TDF/FTC
Physician Decision
|
1
|
|
Treatment A: TMC125 + TDF/FTC
Lost to Follow-up
|
1
|
|
Treatment C: DRV/Rtv + TDF/FTC
Physician Decision
|
1
|
|
Optional Extension: DRV/Rtv + TDF/FTC
Physician Decision
|
1
|
|
Optional Extension: DRV/Rtv + TDF/FTC
Lost to Follow-up
|
2
|
|
Optional Extension: DRV/Rtv + TDF/FTC
Pregnancy
|
1
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
Baseline characteristics by cohort
| Measure |
TDF/FTC +/- TMC125 +/- DRV/Rtv
n=23 Participants
In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
35.87 years
STANDARD_DEVIATION 13.264 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian / White
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*1/CYP2C19*1 : Normal Phenotype
|
5 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*1/CYP2C19*17 : Rapid Phenotype
|
5 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*1/CYP2C19*2 : Intermediate Phenotype
|
7 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*17/CYP2C19*17 : Ultrarapid Phenotype
|
1 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*17/CYP2C19*2 : Normal Phenotype
|
2 participants
n=5 Participants
|
|
CYP2C19 Genotyping
CYP2C19*2/CYP2C19*2 : Poor Phenotype
|
1 participants
n=5 Participants
|
|
CYP2C19 Genotyping
No data
|
2 participants
n=5 Participants
|
|
CYP2C9 Genotyping
CYP2C9*1/CYP2C1*1 : Normal Phenotype
|
19 participants
n=5 Participants
|
|
CYP2C9 Genotyping
CYP2C9*1/CYP2C1*3 : Intermediate Phenotype
|
2 participants
n=5 Participants
|
|
CYP2C9 Genotyping
No data
|
2 participants
n=5 Participants
|
|
Family History Related to Skin Disease
No
|
18 participants
n=5 Participants
|
|
Family History Related to Skin Disease
Yes
|
5 participants
n=5 Participants
|
|
Body Mass Index
|
26.33 kg/m2
STANDARD_DEVIATION 4.629 • n=5 Participants
|
|
Height
|
172.73 cm
STANDARD_DEVIATION 8.405 • n=5 Participants
|
|
Weight
|
78.58 kg
STANDARD_DEVIATION 13.711 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Intention To Treat (ITT) population
At visit Days 14 \& 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=23 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=21 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
DRV/rtv + TDF/FTC
|
Optional Extension
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av
|
23 participants
|
21 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Population: ITT
Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia. Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=21 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=21 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=20 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=18 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia
Grade 1
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia
Grade 2
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Population: ITT
Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia. Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=21 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=21 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=20 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=18 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia
Grade 1
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia
Grade 2
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin. Normal Range: 3.0 - 27.0 ulU/mL
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=21 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=21 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=19 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=16 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin
Above 27.0 ulU/mL
|
1 participant
|
3 participant
|
2 participant
|
3 participant
|
|
Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin
Below 3.0 ulU/mL
|
1 participant
|
2 participant
|
1 participant
|
1 participant
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Population: ITT
Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=21 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=20 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=20 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=7 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral
Grade 1
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral
Grade 2
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Population: ITT
Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL). Normal Range: 40 - 59 mG/dL 1.03 - 1.53 mmol/L
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=14 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=15 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=15 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=7 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)
Below 40 mG/dL (1.03 mmol/L)
|
4 participants
|
8 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)
Above 59 mG/dL (1.53 mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 through 42 and Week 48Population: ITT
Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=21 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=20 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=20 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=7 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct
Grade 2
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct
Grade 1
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 through 48 and Week 48Population: ITT
Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides. Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death.
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=20 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
n=19 Participants
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
n=20 Participants
DRV/rtv + TDF/FTC
|
Optional Extension
n=7 Participants
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides
Grade 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides
Grade 2
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 8, 14, 22, 28, 42 and Week 48Population: ITT
Virologic Response \< 50 HIV-1 RNA Copies/mL (ITT-Observed Case).
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=23 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
DRV/rtv + TDF/FTC
|
Optional Extension
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Day 8 (n=19)
|
0 participants
|
—
|
—
|
—
|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Day 14 (n=21)
|
3 participants
|
—
|
—
|
—
|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Day 22 (n=19)
|
4 participants
|
—
|
—
|
—
|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Day 28 (n=20)
|
6 participants
|
—
|
—
|
—
|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Day 42 (n=20)
|
7 participants
|
—
|
—
|
—
|
|
Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)
Week 48 (n=13)
|
10 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 14, 22, 28 & 42 and Week 48Population: ITT (Observed)
Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case).
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=23 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
DRV/rtv + TDF/FTC
|
Optional Extension
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Baseline (n=23)
|
4.19 copies/mL
Standard Error 0.157
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Day 8 (n=19)
|
-1.41 copies/mL
Standard Error 0.094
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Day 14 (n=21)
|
-1.71 copies/mL
Standard Error 0.090
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Day 22 (n=19)
|
-1.77 copies/mL
Standard Error 0.094
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Day 28 (n=20)
|
-1.86 copies/mL
Standard Error 0.123
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Day 42 (n=20)
|
-2.04 copies/mL
Standard Error 0.127
|
—
|
—
|
—
|
|
Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)
Week 48 (n=13)
|
-2.30 copies/mL
Standard Error 0.237
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 14, 22, 28 & 42 ans Week 48CD4+ Cell Count (x 10\^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case).
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=23 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
DRV/rtv + TDF/FTC
|
Optional Extension
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Baseline (n=23)
|
403.0 x 10^6 cell/L
Interval 144.0 to 895.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 8 (n=20)
|
45.5 x 10^6 cell/L
Interval -126.0 to 209.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 14 (n=20)
|
94.0 x 10^6 cell/L
Interval -78.0 to 426.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 22 (n=20)
|
59.0 x 10^6 cell/L
Interval -184.0 to 251.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 28 (n=21)
|
62.0 x 10^6 cell/L
Interval -170.0 to 329.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 42 (n=19)
|
56.0 x 10^6 cell/L
Interval -221.0 to 472.0
|
—
|
—
|
—
|
|
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)
Week 48 (n=14)
|
160.0 x 10^6 cell/L
Interval -124.0 to 411.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 14, 22, 28 & 42 and Week 48Population: ITT (Observed)
Outcome measures
| Measure |
Treatment A: TMC125 + TDF/FTC
n=23 Participants
Treatment A: TMC125 + TDF/FTC.
|
Treatment B: TMC125 + TDF/FTC + DRV/Rtv
Treatment B: TMC125 + TDF/FTC + DRV/rtv.
|
Treatment C
DRV/rtv + TDF/FTC
|
Optional Extension
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Baseline (n=23)
|
26.2 Percent Change from Baseline
Interval 11.4 to 48.3
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 8 (n=20)
|
0.1 Percent Change from Baseline
Interval -7.7 to 8.1
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 14 (n=20)
|
4.2 Percent Change from Baseline
Interval -3.5 to 10.5
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 22 (n=20)
|
1.8 Percent Change from Baseline
Interval -4.5 to 7.9
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 28 (n=21)
|
3.0 Percent Change from Baseline
Interval -0.9 to 11.2
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Day 42 (n=19)
|
4.2 Percent Change from Baseline
Interval -2.7 to 14.4
|
—
|
—
|
—
|
|
CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)
Week 48 (n=14)
|
3.8 Percent Change from Baseline
Interval -0.2 to 11.5
|
—
|
—
|
—
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Optional Extension
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A
n=23 participants at risk
TMC125 + TDF/FTC
|
Treatment B
n=21 participants at risk
TMC125 + TDF/FTC + DRV/rtv
|
Treatment C
n=21 participants at risk
DRV/rtv + TDF/FTC
|
Optional Extension
n=18 participants at risk
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's Lymphoma
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
Other adverse events
| Measure |
Treatment A
n=23 participants at risk
TMC125 + TDF/FTC
|
Treatment B
n=21 participants at risk
TMC125 + TDF/FTC + DRV/rtv
|
Treatment C
n=21 participants at risk
DRV/rtv + TDF/FTC
|
Optional Extension
n=18 participants at risk
DRV/rtv + TDF/FTC
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne Cystic
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Anogenital Dysplasia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Nervous system disorders
Areflexia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Investigations
Blood Urine Present
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitus
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
11.1%
2/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
9.5%
2/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
16.7%
3/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Injury, poisoning and procedural complications
Drug Exposure During Pregnancy
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
General disorders
Fatigue
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
9.5%
2/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Infections and infestations
Folliculitis
|
4.3%
1/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Nervous system disorders
Intracranial Hypotension
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
19.0%
4/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
11.1%
2/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
2/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Infections and infestations
Syphilis
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
11.1%
2/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
4.8%
1/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/23 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
0.00%
0/21 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
5.6%
1/18 • Baseline, Day 8, 14, 22, 28, 42 and Week 48
|
Additional Information
Vice President, Tibotec Therapeutics Clinical Affairs
Tibotec Therapeutics Clinical Affairs, Division of Centocor Ortho Biotech Services, LLC
Phone: 877-732-2488
Results disclosure agreements
- Principal investigator is a sponsor employee If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.
- Publication restrictions are in place
Restriction type: OTHER