Trial Outcomes & Findings for Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (NCT NCT00486330)

Results Overview

Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

10 days

Results posted on

2020-04-20

Participant Flow

Subjects were recruited from buprenorphine maintenance treatment in New Haven over a year period. Subjects were hospitalized at baseline to be stabilized on buprenorphine/naloxone (BUP/NLX) therapy.

There were no pre-assignment exclusion criteria.

Participant milestones

Participant milestones
Measure	Tipranavir/Ritonavir (500mg/200mg) Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tipranavir/Ritonavir (500mg/200mg) Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
Overall Study Adverse Event	2

Baseline Characteristics

Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tipranavir/Ritonavir (500mg/200mg) n=12 Participants
Age, Continuous	44 years FULL_RANGE 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.

Outcome measures

Outcome measures
Measure	Tipranavir/Ritonavir (500mg/200mg) n=10 Participants Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)	43.7 h*ng/mL Interval 16.4 to 112.7

Adverse Events

Tipranavir/Ritonavir (500mg/200mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tipranavir/Ritonavir (500mg/200mg) n=12 participants at risk
Hepatobiliary disorders Elevated transaminases	8.3% 1/12 • Number of events 1
Nervous system disorders Perioral numbness and lightheadedness	8.3% 1/12 • Number of events 1

Additional Information

R. Douglas Bruce

Yale University AIDS Program

Phone: 2037374040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place