Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications - Full Text View

Sponsor:	University of California, San Francisco
Collaborators:	State University of New York at Buffalo University of Utah
Information provided by (Responsible Party):	Elinore MCance-Katz, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00877591

Purpose

The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir), fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note that we have completed drug interaction studies for buprenorphine with atazanavir, atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university; for this CHR application only the studies needed to be completed at UCSF/SFGH will be discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement application currently pending). Participants are those with opioid dependence who qualify for buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who participate in pharmacokinetics studies of the antiretroviral medications. A total of 160 such individuals will be enrolled in these studies (please note that the studies have been ongoing at Virginia Commonwealth University for 3 years so that the total number of participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s) administered and ability to schedule blood and urine sampling sessions).

Condition	Intervention
Opioid Dependency HIV Infections	Drug: Fosamprenavir/Ritonavir Drug: Darunavir/Ritonavir Drug: Rifampin Drug: Rifabutin Drug: Buprenorphine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Drug Reactions HIV/AIDS Tuberculosis

Drug Information available for: Rifampin Buprenorphine Buprenorphine hydrochloride Rifabutin Ritonavir Darunavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Pharmacokinetics of Buprenorphine with Coadministration of HIV or TB Medications [ Time Frame: 09/07-09/09 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics of HIV Medications with Coadministration of Buprenorphine [ Time Frame: 09/07-09/09 ] [ Designated as safety issue: No ]
Opiate Withdrawal Symptoms [ Time Frame: 09/07-09-09 ] [ Designated as safety issue: No ]
Cognitive Function [ Time Frame: 09/07-09/09 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 09/07-09-09 ] [ Designated as safety issue: No ]
Cardiac Conduction [ Time Frame: 09/07-09-09 ] [ Designated as safety issue: No ]
Hepatic Function [ Time Frame: 09/07-09-09 ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Buprenorphine + Fosamprenavir/Ritonavir	Drug: Fosamprenavir/Ritonavir 1400/200 mg once daily for 15 days total Other Name: Lexiva/Norvir Drug: Buprenorphine 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 Name: Suboxone
Active Comparator: 2 Control Fosamprenavir/Ritonavir	Drug: Fosamprenavir/Ritonavir 1400/200 mg once daily for 15 days total Other Name: Lexiva/Norvir
Experimental: 3 Buprenorphine + Darunavir/Ritonavir	Drug: Darunavir/Ritonavir 800/100 mg once daily for 15 days total Other Name: Prezista/Norvir Drug: Buprenorphine 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 Name: Suboxone
Active Comparator: 4 Control Darunavir/Ritonavir	Drug: Darunavir/Ritonavir 800/100 mg once daily for 15 days total Other Name: Prezista/Norvir
Experimental: 5 Buprenorphine + Rifampin	Drug: Rifampin 600 mg once daily for 15 days total Drug: Buprenorphine 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 Name: Suboxone
Experimental: 6 Buprenorphine + Rifabutin	Drug: Rifabutin 300 mg once daily for 15 days total Drug: Buprenorphine 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 Name: Suboxone

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877591

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

State University of New York at Buffalo

University of Utah

Investigators

Principal Investigator:

Elinore F McCance-Katz, M.D., Ph.D.

University of California, San Francisco

More Information

No publications provided

Responsible Party:	Elinore MCance-Katz, Adjunct Professor, Dept of Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00877591 History of Changes
Other Study ID Numbers:	R01DA013004
Study First Received:	April 7, 2009
Last Updated:	September 15, 2011
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Interaction of Buprenorphine with HIV and TB Medications

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections

Bacterial Infections
Buprenorphine
Rifampin
Rifabutin
Ritonavir
Fosamprenavir
Darunavir
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012