Trial Outcomes & Findings for Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir) (NCT NCT00571961)

Results Overview

Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

15 days

Results posted on

2012-11-21

Participant Flow

HIV negative subjects currently enrolled in a long-term buprenorphine maintenance therapy program for at least 3 months who have been on stable dose of buprenorphine/naloxone (BUP/NLX) for at least 3 weeks will be admitted to the General Clinical Research Center (GCRC) for pharmacokinetic (PK) blood draws at intervals over a 24-hour period.

Once admitted to the GCRC, subjects were maintained on 16 mg of BUP/NLX daily, except for 1 patient on 24 mg. As baseline, subjects on steady-state BUP/NLX were hospitalized and underwent pharmacokinetic investigation over a 24-hr period. Subjects served as their own controls.

Participant milestones

Participant milestones
Measure	Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg n=12 Participants Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
Age Continuous	42 years FULL_RANGE 1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days

Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.

Outcome measures

Outcome measures
Measure	Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg n=12 Participants Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)	46.2 (ng/mL)*hr Standard Deviation 15.3

Adverse Events

Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

R. Douglas Bruce, MD, MA, MSc

Yale University AIDS Program

Phone: (203) 737-6133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place