Trial Outcomes & Findings for Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. (NCT NCT01258374)
NCT ID: NCT01258374
Last Updated: 2019-09-27
Results Overview
Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.
COMPLETED
15 participants
After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.
2019-09-27
Participant Flow
The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. 15 patients were screenend and all of them were included and finish the study
Participant milestones
| Measure |
Single Arm With Dual Therapy
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Raltegravir: Raltegravir, 400 mg bid
Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
Baseline characteristics by cohort
| Measure |
Single Arm With Dual Therapy
n=15 Participants
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Raltegravir: Raltegravir, 400 mg bid
Darunavir: Darunavir, 800 mg QD + ritonavir 100 mg QD
|
|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.Population: HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled
Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.
Outcome measures
| Measure |
Single Arm With Dual Therapy
n=15 Participants
Fifteen patients were screened and enrolled, and all of them completed the study procedures. The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily.
Inclusion criteria were HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. All doses of RAL were administered in the morning and evening, orally with food (light meal). Patients were admitted to the hospital in the morning on day 15 and stayed for 12 hours after the last administration of RAL. The morning dose of RAL and DRV/ RTV was administered in the clinic with a light breakfast (200 mL of whole milk and a ham and cheese sandwich), and blood samples were drawn immediately before breakfast and 0.5 1, 2, 3, 4, 6, 8, 12, and 24 hours afterward
|
|---|---|
|
Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
C trough Darunavir
|
1330 ng/ml
Interval 1110.0 to 1760.0
|
|
Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
C trough Raltegravir
|
40 ng/ml
Interval 30.0 to 80.0
|
|
Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
C trough Ritonavir
|
90 ng/ml
Interval 70.0 to 140.0
|
PRIMARY outcome
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.Population: HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled
Geometric mean of AUC0 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.
Outcome measures
| Measure |
Single Arm With Dual Therapy
n=15 Participants
Fifteen patients were screened and enrolled, and all of them completed the study procedures. The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily.
Inclusion criteria were HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. All doses of RAL were administered in the morning and evening, orally with food (light meal). Patients were admitted to the hospital in the morning on day 15 and stayed for 12 hours after the last administration of RAL. The morning dose of RAL and DRV/ RTV was administered in the clinic with a light breakfast (200 mL of whole milk and a ham and cheese sandwich), and blood samples were drawn immediately before breakfast and 0.5 1, 2, 3, 4, 6, 8, 12, and 24 hours afterward
|
|---|---|
|
Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
AUC Raltegravir
|
3050 ng.h/mL
Interval 2530.0 to 5180.0
|
|
Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
AUC Darunavir
|
68,730 ng.h/mL
|
|
Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
AUC Ritonavir
|
5470 ng.h/mL
Interval 4500.0 to 7420.0
|
PRIMARY outcome
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.Population: HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled
Geometric mean of C-max of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-max, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.
Outcome measures
| Measure |
Single Arm With Dual Therapy
n=15 Participants
Fifteen patients were screened and enrolled, and all of them completed the study procedures. The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily.
Inclusion criteria were HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. All doses of RAL were administered in the morning and evening, orally with food (light meal). Patients were admitted to the hospital in the morning on day 15 and stayed for 12 hours after the last administration of RAL. The morning dose of RAL and DRV/ RTV was administered in the clinic with a light breakfast (200 mL of whole milk and a ham and cheese sandwich), and blood samples were drawn immediately before breakfast and 0.5 1, 2, 3, 4, 6, 8, 12, and 24 hours afterward
|
|---|---|
|
Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
Cmax Darunavir
|
7630 ng/mL
Interval 6740.0 to 9000.0
|
|
Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
Cmax Raltegravir
|
970 ng/mL
Interval 840.0 to 2270.0
|
|
Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
Cmax Ritonavir
|
490 ng/mL
Interval 410.0 to 630.0
|
PRIMARY outcome
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.Population: HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled
Geometric mean of t1/2 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of t1/2, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.
Outcome measures
| Measure |
Single Arm With Dual Therapy
n=15 Participants
Fifteen patients were screened and enrolled, and all of them completed the study procedures. The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily.
Inclusion criteria were HIV-1-infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. All doses of RAL were administered in the morning and evening, orally with food (light meal). Patients were admitted to the hospital in the morning on day 15 and stayed for 12 hours after the last administration of RAL. The morning dose of RAL and DRV/ RTV was administered in the clinic with a light breakfast (200 mL of whole milk and a ham and cheese sandwich), and blood samples were drawn immediately before breakfast and 0.5 1, 2, 3, 4, 6, 8, 12, and 24 hours afterward
|
|---|---|
|
Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy
t1/2 Darunavir
|
10.91 h
Interval 9.2 to 13.99
|
|
Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy
t1/2 Raltegravir
|
2.68 h
Interval 1.97 to 4.4
|
|
Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy
t1/2 Ritonavir
|
9.48 h
Interval 8.15 to 11.63
|
Adverse Events
Single Arm With Dual Therapy
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