Trial Outcomes & Findings for Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients (NCT NCT01190124)

NCT ID: NCT01190124

Last Updated: 2011-05-19

Results Overview

Patients with undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at baseline.

• Recruitment status: COMPLETED
• Target enrollment: 151 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2011-05-19

Participant Flow

Retrospective collection of data took place in 11 portuguese public hospitals. Each site included patients who started treatment with raltegravir from March 2007 until December 2008.

197 patients were included in the database. However, only 151 patients were included in the analysis, as 46 did not meet inclusion/exclusion criteria

Participant milestones

Measure	HIV-1 at Virologic Failure Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Study STARTED	107	24	20
Overall Study COMPLETED	90	24	19
Overall Study NOT COMPLETED	17	0	1

Reasons for withdrawal

Measure	HIV-1 at Virologic Failure Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Study Death	3	0	0
Overall Study Therapeutic Failure	12	0	1
Overall Study Lost to Follow-up	2	0	0

Baseline Characteristics

Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients

Baseline characteristics by cohort

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)	Total n=151 Participants Total of all reporting groups
Age Continuous	44.0 years FULL_RANGE 10.2 • n=5 Participants	45.5 years FULL_RANGE 12.7 • n=7 Participants	52.5 years FULL_RANGE 11.6 • n=5 Participants	45.0 years FULL_RANGE 10.9 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	114 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	0 participants	24 participants	10 participants
HIV-RNA Levels >= 50 copies/mL	107 participants	0 participants	10 participants

PRIMARY outcome

Timeframe: week 24

Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels >= 50 copies / mL	27 participants	0 participants	2 participants
HIV-RNA Levels Missing value	5 participants	0 participants	1 participants
HIV-RNA Levels < 50 copies / mL	75 participants	24 participants	17 participants

PRIMARY outcome

Timeframe: week 48

Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	74 participants	24 participants	16 participants
HIV-RNA Levels >= 50 copies/mL	18 participants	0 participants	3 participants
HIV-RNA Levels Missing value	15 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: Baseline

CD4 cells count at baseline.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	166.00 cells/mm^3 Full Range 203.57 • Interval 3.0 to 856.0	391 cells/mm^3 Full Range 200.77 • Interval 120.0 to 925.0	120 cells/mm^3 Full Range 104.66 • Interval 15.0 to 430.0

PRIMARY outcome

Timeframe: week 24

CD4 cells count at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	299.50 cells/mm^3 Full Range 272.28 • Interval 26.0 to 1409.0	389.00 cells/mm^3 Full Range 183.18 • Interval 171.0 to 864.0	190.00 cells/mm^3 Full Range 156.83 • Interval 57.0 to 591.0

PRIMARY outcome

Timeframe: week 48

CD4 cells count at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 Participants Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 Participants Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	336.50 cells/mm^3 Full Range 3108.80 • Interval 18.0 to 29760.0	452.00 cells/mm^3 Full Range 174.25 • Interval 170.0 to 823.0	180.00 cells/mm^3 Full Range 160.26 • Interval 49.0 to 703.0

SECONDARY outcome

Timeframe: Baseline

For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	20 participants	—	—
HIV-RNA Levels >= 50 copies/mL	0 participants	—	—

SECONDARY outcome

Timeframe: Week 24

For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	20 participants	—	—
HIV-RNA Levels >= 50 copies/mL	0 participants	—	—

SECONDARY outcome

Timeframe: Week 48

For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	20 participants	—	—
HIV-RNA Levels >= 50 copies/mL	0 participants	—	—

SECONDARY outcome

Timeframe: Baseline

For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	400.50 cells/mm^3 Full Range 193.50 • Interval 120.0 to 925.0	—	—

SECONDARY outcome

Timeframe: Week 24

For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	378.00 cells/mm^3 Full Range 171.00 • Interval 171.0 to 864.0	—	—

SECONDARY outcome

Timeframe: Week 48

For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=107 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	452.00 cells/mm^3 Full Range 181.99 • Interval 170.0 to 823.0	—	—

SECONDARY outcome

Timeframe: Baseline

For the HIV-2 infected patients CD4 cells count will be assessed at baseline.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	120.00 cells/mm^3 Full Range 104.66 • Interval 15.0 to 430.0	—	—

SECONDARY outcome

Timeframe: Week 24

For the HIV-2 infected patients CD4 cells count will be assessed at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	190.00 cells/mm^3 Full Range 156.83 • Interval 57.0 to 591.0	—	—

SECONDARY outcome

Timeframe: Week 48

For the HIV-2 infected patients CD4 cells count will be assessed at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
CD4 Cells Count	180.00 cells/mm^3 Full Range 160.00 • Interval 49.0 to 703.0	—	—

SECONDARY outcome

Timeframe: Baseline

For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	10 participants	—	—
HIV-RNA Levels >= 50 copies/mL	10 participants	—	—

SECONDARY outcome

Timeframe: Week 24

For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	17 participants	—	—
HIV-RNA Levels >= 50 copies/mL	2 participants	—	—
HIV-RNA Levels Missing value	1 participants	—	—

SECONDARY outcome

Timeframe: Week 48

For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.

Outcome measures

Measure	HIV-1 at Virologic Failure n=20 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
HIV-RNA Levels < 50 copies/mL	16 participants	—	—
HIV-RNA Levels >= 50 copies/mL	3 participants	—	—
HIV-RNA Levels Missing value	1 participants	—	—

SECONDARY outcome

Timeframe: Week 48

Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.

Outcome measures

Measure	HIV-1 at Virologic Failure n=151 Participants Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Adverse Drug Reactions At least one adverse reaction	12 participants	—	—
Adverse Drug Reactions At least one non serious adverse reaction	9 participants	—	—
Adverse Drug Reactions At least one serious adverse reaction	3 participants	—	—
Adverse Drug Reactions Patients that discontinued due to adverse reaction	0 participants	—	—

Adverse Events

HIV-1 at Virologic Failure

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

HIV With Need for Therapy Change

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

HIV-2 With Therapeutic Failure

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	HIV-1 at Virologic Failure n=107 participants at risk Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 participants at risk Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 participants at risk Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Vascular disorders Edema of the lower extremities	0.93% 1/107 • Number of events 1	0.00% 0/24	0.00% 0/20
Skin and subcutaneous tissue disorders Toxidermia	0.93% 1/107 • Number of events 1	0.00% 0/24	0.00% 0/20
Surgical and medical procedures Anemia	0.93% 1/107 • Number of events 1	0.00% 0/24	0.00% 0/20

Other adverse events

Measure	HIV-1 at Virologic Failure n=107 participants at risk Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV \>1000 cop/mL)	HIV With Need for Therapy Change n=24 participants at risk Adult HIV infected patients at virologic suppression (with RNA HIV \<40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)	HIV-2 With Therapeutic Failure n=20 participants at risk Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Nervous system disorders Somnolence	1.9% 2/107 • Number of events 2	0.00% 0/24	0.00% 0/20
Gastrointestinal disorders Diarrhea	1.9% 2/107 • Number of events 2	0.00% 0/24	0.00% 0/20
Psychiatric disorders Hallucinations	0.93% 1/107 • Number of events 1	0.00% 0/24	0.00% 0/20
Blood and lymphatic system disorders Anemia	0.93% 1/107 • Number of events 1	0.00% 0/24	0.00% 0/20
Metabolism and nutrition disorders Elevated CPK	0.93% 1/107 • Number of events 1	0.00% 0/24	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders Elevated AST/ALT	0.00% 0/107	4.2% 1/24 • Number of events 1	0.00% 0/20

Additional Information

Doroana, Maria Manuela, M.D.

Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

Phone: 351 217938043

Email: manuela.doroana@hsm.min-saude.pt

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place