- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877591
Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- San Francisco General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects will be in good health as determined by a physical examination and screening laboratory tests and urinalysis, and will meet the criteria of opioid dependence, but will not be physiologically dependent on any other drugs or alcohol; those with history of current binge alcohol use will also be excluded. Subjects will be enrolled in buprenorphine treatment and must be on a stable, standard clinical dose (4-20 mg/d) for at least 2 weeks prior to initiation of pharmacokinetics study.
- Control subjects who are non-opioid dependent, are not physiologically dependent on any other drugs or alcohol and volunteer for the HIV medications pharmacokinetics studies alone must be in good health as determined by a physical examination and screening laboratory studies as described below.
- Age 18 or older.
- Able to give voluntary, signed, informed consent.
Exclusion Criteria:
- Patients who are receiving concurrently other drugs that are inducers or inhibitors of hepatic microsomal enzymes.
- Patients with a known sensitivity to the HIV therapeutics to be studied.
- Pregnant women or nursing mothers. All women who are sexually active and capable of becoming pregnant must have a negative pregnancy test within one week prior to entry into these studies.
- Major psychotic illness or suicidality.
- Clinically active hepatitis (primarily Hepatitis B or C in opioid dependent subjects) with liver enzyme elevations > 3 times the upper limit of normal
- Those with diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Buprenorphine + Fosamprenavir/Ritonavir
|
1400/200 mg once daily for 15 days total
Other Names:
FOSAMPRENAVIR/RITONAVIR Dosing information: 1400 mg fosamprenavir + 200 mg ritonavir once daily for 15 days DARUNAVIR/RITONAVIR Dosing information: 800 mg darunavir + 100 mg ritonavir once daily for 15 days RIFAMPIN Dosing information: 600 mg once daily in the morning for 15 days RIFABUTIN Dosing information: 300 mg once daily in the morning for 15 days
Other Names:
|
Active Comparator: 2
Control Fosamprenavir/Ritonavir
|
1400/200 mg once daily for 15 days total
Other Names:
|
Experimental: 3
Buprenorphine + Darunavir/Ritonavir
|
FOSAMPRENAVIR/RITONAVIR Dosing information: 1400 mg fosamprenavir + 200 mg ritonavir once daily for 15 days DARUNAVIR/RITONAVIR Dosing information: 800 mg darunavir + 100 mg ritonavir once daily for 15 days RIFAMPIN Dosing information: 600 mg once daily in the morning for 15 days RIFABUTIN Dosing information: 300 mg once daily in the morning for 15 days
Other Names:
800/100 mg once daily for 15 days total
Other Names:
|
Active Comparator: 4
Control Darunavir/Ritonavir
|
800/100 mg once daily for 15 days total
Other Names:
|
Experimental: 5
Buprenorphine + Rifampin
|
FOSAMPRENAVIR/RITONAVIR Dosing information: 1400 mg fosamprenavir + 200 mg ritonavir once daily for 15 days DARUNAVIR/RITONAVIR Dosing information: 800 mg darunavir + 100 mg ritonavir once daily for 15 days RIFAMPIN Dosing information: 600 mg once daily in the morning for 15 days RIFABUTIN Dosing information: 300 mg once daily in the morning for 15 days
Other Names:
600 mg once daily for 15 days total
|
Experimental: 6
Buprenorphine + Rifabutin
|
FOSAMPRENAVIR/RITONAVIR Dosing information: 1400 mg fosamprenavir + 200 mg ritonavir once daily for 15 days DARUNAVIR/RITONAVIR Dosing information: 800 mg darunavir + 100 mg ritonavir once daily for 15 days RIFAMPIN Dosing information: 600 mg once daily in the morning for 15 days RIFABUTIN Dosing information: 300 mg once daily in the morning for 15 days
Other Names:
300 mg once daily for 15 days total
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of ARV or Tuberculosis Medication on Buprenorphine
Time Frame: 2007-2010
|
2007-2010
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Protease Inhibitors
- Anti-Bacterial Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Buprenorphine
- Ritonavir
- Rifampin
- Rifabutin
- Darunavir
- Fosamprenavir
Other Study ID Numbers
- R01DA013004 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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