Trial Outcomes & Findings for Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression (NCT NCT01511809)
NCT ID: NCT01511809
Last Updated: 2024-02-09
Results Overview
Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)\>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA \<50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).
COMPLETED
PHASE3
117 participants
Up to week 48
2024-02-09
Participant Flow
Participant milestones
| Measure |
Atazanavir/Ritonavir Monotherapy
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
|
Atazanavir/Ritonavir Triple Therapy
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
|
Overall Study
COMPLETED
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
Baseline characteristics by cohort
| Measure |
Atazanavir/Ritonavir Monotherapy
n=51 Participants
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
|
Atazanavir/Ritonavir Triple Therapy
n=52 Participants
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
n=5 Participants
|
41.7 years
n=7 Participants
|
41.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
51 participants
n=5 Participants
|
52 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
nadir CD4+
|
274 cells/mm3
n=5 Participants
|
278 cells/mm3
n=7 Participants
|
276 cells/mm3
n=5 Participants
|
|
Years of antiretroviral treatment
|
25 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
|
HIV-1 RNA <50 copies/ml
|
20 months
n=5 Participants
|
18 months
n=7 Participants
|
19 months
n=5 Participants
|
|
HIV-RNA at ARV start
|
79399 copies/mL
n=5 Participants
|
42630 copies/mL
n=7 Participants
|
59062 copies/mL
n=5 Participants
|
|
CD4+
|
599 cells/mm3
n=5 Participants
|
570 cells/mm3
n=7 Participants
|
575 cells/mm3
n=5 Participants
|
|
HCV coinfection
Present
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
HCV coinfection
Absent
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to week 48Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)\>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA \<50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).
Outcome measures
| Measure |
Atazanavir/Ritonavir Monotherapy
n=51 Participants
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
|
Atazanavir/Ritonavir Triple Therapy
n=52 Participants
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
|
|---|---|---|
|
Proportion of Patients With Treatment Failure (TF)
ITT=Failure analysis
|
27.5 percentage of patients
|
15.4 percentage of patients
|
|
Proportion of Patients With Treatment Failure (TF)
ITT=Success analysis
|
7.9 percentage of patients
|
15.4 percentage of patients
|
SECONDARY outcome
Timeframe: week 96Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts. Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure. Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation. Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups.
Outcome measures
Outcome data not reported
Adverse Events
Atazanavir/Ritonavir Monotherapy
Atazanavir/Ritonavir Triple Therapy
Serious adverse events
| Measure |
Atazanavir/Ritonavir Monotherapy
n=51 participants at risk
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
|
Atazanavir/Ritonavir Triple Therapy
n=52 participants at risk
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
|
|---|---|---|
|
Cardiac disorders
acute coronary stenosis
|
2.0%
1/51 • Up to week 48
|
0.00%
0/52 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
left basal pneumonia
|
2.0%
1/51 • Up to week 48
|
0.00%
0/52 • Up to week 48
|
Other adverse events
| Measure |
Atazanavir/Ritonavir Monotherapy
n=51 participants at risk
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
|
Atazanavir/Ritonavir Triple Therapy
n=52 participants at risk
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
|
|---|---|---|
|
Hepatobiliary disorders
acute hepatitis
|
2.0%
1/51 • Up to week 48
|
1.9%
1/52 • Up to week 48
|
|
Renal and urinary disorders
nephrolitiasis
|
0.00%
0/51 • Up to week 48
|
3.8%
2/52 • Up to week 48
|
|
Hepatobiliary disorders
cholecystitis due to cholelithiasis
|
0.00%
0/51 • Up to week 48
|
1.9%
1/52 • Up to week 48
|
|
Renal and urinary disorders
hyperuricemia
|
0.00%
0/51 • Up to week 48
|
1.9%
1/52 • Up to week 48
|
|
Renal and urinary disorders
gross haematuria with proteinuria
|
0.00%
0/51 • Up to week 48
|
3.8%
2/52 • Up to week 48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place