Trial Outcomes & Findings for Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS (NCT NCT02155101)
NCT ID: NCT02155101
Last Updated: 2019-09-04
Results Overview
Percentage of subjects who have plasma HIV-1 RNA levels \<400 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method). The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
81
|
|
Overall Study
COMPLETED
|
39
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS
Baseline characteristics by cohort
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 Participants
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 Participants
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=99 Participants
|
45 years
n=107 Participants
|
45 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
Cameroon
|
39 participants
n=99 Participants
|
81 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Body mass index
|
26.0 kg/m^2
n=99 Participants
|
25.4 kg/m^2
n=107 Participants
|
25.5 kg/m^2
n=206 Participants
|
|
Haemoglobin
|
12.4 g/dl
n=99 Participants
|
12.3 g/dl
n=107 Participants
|
12.3 g/dl
n=206 Participants
|
|
Estimated glomerular filtration rate >90
|
35 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Time since HIV diagnosis
|
8.0 years
n=99 Participants
|
8.8 years
n=107 Participants
|
8.5 years
n=206 Participants
|
|
CD4 cell count
|
536 cells/mm3
n=99 Participants
|
466 cells/mm3
n=107 Participants
|
467 cells/mm3
n=206 Participants
|
|
History of previous AIDS defining diagnosis
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
HIV-1 DNA
|
2.7 log10 copies/106 PBMC
n=99 Participants
|
2.9 log10 copies/106 PBMC
n=107 Participants
|
2.9 log10 copies/106 PBMC
n=206 Participants
|
|
Duration on antiretroviral therapy(ART)
|
6.9 years
n=99 Participants
|
7.6 years
n=107 Participants
|
7.5 years
n=206 Participants
|
|
Duration on protease inhibitor based ART
|
3.1 years
n=99 Participants
|
3.2 years
n=107 Participants
|
3.1 years
n=206 Participants
|
|
ART regimen at baseline
Tenofovir/lamivudine + lopinavir/ritonavir
|
37 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
ART regimen at baseline
Abacavir + didanosine + lopinavir/ritonavir
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
ART regimen at baseline
Zidovudine/lamivudine + lopinavir/ritonavir
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
ART regimen at baseline
Tenofovir/lamivudine + atazanavir/ritonavir
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ART regimen at baseline
Tenofovir + abacavir + lopinavir/ritonavir
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPercentage of subjects who have plasma HIV-1 RNA levels \<400 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method). The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48.
Outcome measures
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 Participants
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 Participants
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
HIV-1 RNA Viral Load
|
37 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPercentage of subjects who have plasma HIV-1 RNA levels \<50 cps/ml after 12 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA "Time to Loss of Virologic Response" method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 12 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48.
Outcome measures
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 Participants
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 Participants
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
HIV-1 RNA Viral Load
|
35 Participants
|
73 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPercentage of subjects who have plasma HIV-1 RNA levels \<50 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA "Time to Loss of Virologic Response" method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48.
Outcome measures
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 Participants
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 Participants
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
HIV-1 RNA Viral Load
|
36 Participants
|
62 Participants
|
Adverse Events
ART With 2 NRTIs Plus LPV/r (or ATV/r)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Darunavir
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 participants at risk
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 participants at risk
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
Social circumstances
Car accident, hospitalisation, resolved;
|
0.00%
0/39 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
|
General disorders
acute anxiety, hospitalisation, resolved
|
0.00%
0/39 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
|
Infections and infestations
malaria, progressive anaemia, hospitalisation, transfusion reaction, death
|
0.00%
0/39 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
Other adverse events
| Measure |
ART With 2 NRTIs Plus LPV/r (or ATV/r)
n=39 participants at risk
2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r).
ART with 2 NRTIs plus LPV/r (or ATV/r): Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
|
Darunavir
n=81 participants at risk
Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with "400 mg" on one side and TMC on the other side.
Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
|
|---|---|---|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/39 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
|
General disorders
Acute febrile illness
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
0.00%
0/81 • Adverse event data was collected over the 48 week study period
|
|
General disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
|
Infections and infestations
Pulmonary TB
|
0.00%
0/39 • Adverse event data was collected over the 48 week study period
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 48 week study period
|
Additional Information
Professor Anna Maria Geretti
University of Liverpool
Phone: +44(0)151 795 9625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60