Trial Outcomes & Findings for DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects (NCT NCT01423812)
NCT ID: NCT01423812
Last Updated: 2023-07-19
Results Overview
Proportion of subjects with plasma HIV-1 RNA \<40 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's "snapshot" algorithm
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
48 weeks after randomization to study medication
Results posted on
2023-07-19
Participant Flow
Participant milestones
| Measure |
Once-daily Darunavir/Ritonavir
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Once-daily Darunavir/Ritonavir
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
Baseline characteristics by cohort
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
48 years
n=93 Participants
|
49 years
n=4 Participants
|
48 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
60 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48 weeks after randomization to study medicationProportion of subjects with plasma HIV-1 RNA \<40 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's "snapshot" algorithm
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects
|
27 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Within 24 weeks after randomization to study medicationPopulation: Population for outcome of subjects with plasma HIV-1 RNA \>200 copies/ML at week 24
•Proportion of subjects with plasma HIV-1 RNA \>200 c/mL at Week 24
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Secondary Efficacy Endpoints
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 48 weeks of randomization baseline to study medicationsPopulation: Mean within person change in total cholesterol mg/dl from baseline
Absolute change in lipid parameter (total cholesterol mg/dl) of once-daily versus twice-daily darunavir/ritonavir containing regimens over 48 weeks
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Change in Total Cholesterol From Baseline to 48 Weeks
|
-14.2 mg/dl
Standard Error 0.148
|
-3.8 mg/dl
Standard Error 0.148
|
SECONDARY outcome
Timeframe: 48 weeks after randomization baseline to study medicationsPopulation: Population for outcome of subjects measuring absolute change in CD4+ at week 48
Absolute value increase in CD4+ cells/mm3 from baseline to week 48
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Absolute Value Change in CD4+ From Baseline to Week 48
|
19 cells/mm3
Standard Error 0.592
|
39 cells/mm3
Standard Error 0.592
|
SECONDARY outcome
Timeframe: Within 48 weeks of randomization to study medications•Assess the development of viral resistance in subjects experiencing virological failure
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Assessment of Virologic Failure
|
0 participants with resistance for failure
|
0 participants with resistance for failure
|
SECONDARY outcome
Timeframe: Within 48 weeks of randomization to study medicationsPopulation: Percentage of \>95% adherence at week 48
Characterize adherence to once-daily versus twice-daily darunavir/ritonavir containing regimens using the Modified Medication Adherence Self-Report Inventory (M-MASRI) scale
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=27 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=27 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Number of Participants With Greater Than 95% Adherence at 48 Weeks
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: week 24•Proportion of subjects with plasma HIV-1 RNA \<40 c/mL at Week 24
Outcome measures
| Measure |
Once-daily Darunavir/Ritonavir
n=30 Participants
Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily
Once-daily Darunavir/ritonavir: Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
|
Twice-daily Darunavir/Ritonavir
n=30 Participants
Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
Twice-daily Darunavir/ritonavir: Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
|
|---|---|---|
|
Secondary Efficacy Endpoints
|
29 Participants
|
25 Participants
|
Adverse Events
Once-daily Darunavir/Ritonavir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Twice-daily Darunavir/Ritonavir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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