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:	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, atazanvir/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:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Resource links provided by NLM:

MedlinePlus related topics: 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:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: Justine N Arenander, B.A.

(415) 206-5595

justine.arenander@ucsf.edu

Locations

United States, California
San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Elinore F McCance-Katz, M.D., Ph.D.

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:	University of California, San Francisco ( Elinore McCance-Katz, MD, PhD, Adjunct Professor )
Study ID Numbers:	R01DA013004
Study First Received:	April 7, 2009
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00877591 History of Changes
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:

Bacterial Infections
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Rifabutin
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Buprenorphine
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses

Tuberculosis
Analgesics
Retroviridae Infections
Analgesics, Opioid
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010