Trial Outcomes & Findings for Switch to Unboosted Atazanavir With Tenofovir Study (NCT NCT01351740)

NCT ID: NCT01351740

Last Updated: 2018-07-30

Results Overview

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load \>400 copies/mL on 2 consecutive measurements \>2 weeks apart.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: at or before 48 weeks.
• Results posted on: 2018-07-30

Participant Flow

Participant milestones

Measure	Switch switch to unboosted atazanavir 400mg daily with the same nucleoside (NRTI) backbone atazanavir: switch to unboosted atazanavir 400 mg daily	Continuation continue on current regimen of atazanavir/ritonavir 300mg/100mg with the same nucleoside (NRTI) backbone atazanavir/ritonavir: Continue current regimen of atazanavir 300 mg/ ritonavir 100 mg daily
Overall Study STARTED	25	25
Overall Study COMPLETED	23	19
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Switch to Unboosted Atazanavir With Tenofovir Study

Baseline characteristics by cohort

Measure	Switch n=25 Participants Switch to atazanavir 400 mg daily	Continuation n=25 Participants Remain on atazanavir/ritonavir 300mg/100 mg daily	Total n=50 Participants Total of all reporting groups
Age, Continuous	48 years n=5 Participants	46 years n=7 Participants	47 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: at or before 48 weeks.

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.

Outcome measures

Measure	Switch n=25 Participants Switch to atazanavir 400 mg daily	Continuation n=25 Participants Remain on atazanavir/ritonavir 300mg/100mg daily
Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 month (4-8 weeks)

Therapeutic drug monitoring (TDM) to determine atazanavir trough plasma level will be performed once on all subjects at 4-8 weeks

Outcome measures

Measure	Switch n=24 Participants Switch to atazanavir 400 mg daily	Continuation n=12 Participants Remain on atazanavir/ritonavir 300mg/100mg daily
Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL	14 Participants	3 Participants

SECONDARY outcome

Timeframe: at or before 48 weeks

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at or before 24 weeks.

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at or before 24 weeks

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 weeks

Comparison will be made between randomized treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 weeks

Serious adverse events and discontinuations will be compared between randomized treatment arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 weeks

Comparison will be made between randomized treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 weeks

Comparison will be made between randomized treatment arms with respect to changes in fasting lipids and glucose, highly sensitive C-reactive protein [hsCRP], and apolipoprotein [apo]B, and proportions of subjects developing abnormalities or crossing predefined limits (e.g. NCEP thresholds for lipids)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 weeks

Changes in MOS-HIV scores from baseline will be compared between randomized treatment arms.

Outcome measures

Outcome data not reported

Adverse Events

Switch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Switch n=25 participants at risk Switch to atazanavir 400 mg daily	Continuation n=25 participants at risk Remain on atazanavir/ritonavir 300 mg/100 mg daily
Gastrointestinal disorders diarrhea	0.00% 0/25 • 48 weeks	4.0% 1/25 • 48 weeks
Renal and urinary disorders renal toxicity	0.00% 0/25 • 48 weeks	8.0% 2/25 • 48 weeks

Additional Information

Dr Marianne Harris

British Columbia Centre for Excellence in HIV/AIDS

Phone: 1-604-806-8771

Email: mharris@cfenet.ubc.ca

Results disclosure agreements

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