Trial Outcomes & Findings for Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study (NCT NCT04707326)
NCT ID: NCT04707326
Last Updated: 2024-12-20
Results Overview
Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
2040 participants
Primary outcome timeframe
1 year
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
DTG Based Switchers to DTG/3TC
HIVRNA suppressed HIV patients who switched to DTG/3TC
|
DTG Based Triple Drug cART
Matched HIVRNA suppressed patients who remained on triple drug DTG based cART
|
Non-DTG Based Switchers to DTG/3TC
Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B
|
Non-DTG Based Triple Drug cART
Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
390
|
780
|
290
|
580
|
|
Overall Study
COMPLETED
|
390
|
780
|
290
|
580
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study
Baseline characteristics by cohort
| Measure |
DTG Based Switchers to DTG/3TC
n=390 Participants
HIVRNA suppressed HIV patients who switched to DTG/3TC
|
DTG Based Triple Drug cART
n=780 Participants
Matched HIVRNA suppressed patients who remained on triple drug DTG based cART
|
Non-DTG Based Switchers to DTG/3TC
n=290 Participants
Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B
|
Non-DTG Based Triple Drug cART
n=580 Participants
Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART
|
Total
n=2040 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
48 years
n=7 Participants
|
50 years
n=5 Participants
|
50 years
n=4 Participants
|
49 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
321 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
344 Participants
n=5 Participants
|
688 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
1719 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
248 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
356 Participants
n=5 Participants
|
680 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
501 Participants
n=4 Participants
|
1792 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
CD4 count nadir
|
330 cells/mcL
n=5 Participants
|
310 cells/mcL
n=7 Participants
|
290 cells/mcL
n=5 Participants
|
270 cells/mcL
n=4 Participants
|
300 cells/mcL
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearProportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population
Outcome measures
| Measure |
DTG Based Switchers to DTG/3TC
n=361 Participants
HIVRNA suppressed HIV patients who switched to DTG/3TC
|
DTG Based Triple Drug cART
n=628 Participants
Matched HIVRNA suppressed patients who remained on triple drug DTG based cART
|
Non-DTG Based Switchers to DTG/3TC
n=260 Participants
Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B
|
Non-DTG Based Triple Drug cART
n=506 Participants
Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART
|
|---|---|---|---|---|
|
Efficacy On Treatment (OT)
|
5 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 yearProportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the intention to treat population.
Outcome measures
| Measure |
DTG Based Switchers to DTG/3TC
n=390 Participants
HIVRNA suppressed HIV patients who switched to DTG/3TC
|
DTG Based Triple Drug cART
n=780 Participants
Matched HIVRNA suppressed patients who remained on triple drug DTG based cART
|
Non-DTG Based Switchers to DTG/3TC
n=290 Participants
Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B
|
Non-DTG Based Triple Drug cART
n=580 Participants
Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART
|
|---|---|---|---|---|
|
Efficacy Intention to Treat (ITT)
|
34 Participants
|
89 Participants
|
32 Participants
|
73 Participants
|
Adverse Events
DTG Based Switchers to DTG/3TC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DTG Based Triple Drug cART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-DTG Based Switchers to DTG/3TC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-DTG Based Triple Drug cART
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