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Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

This study has been completed.
Sponsor:
Collaborators:
State University of New York at Buffalo
University of Utah
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00877591
First received: April 7, 2009
Last updated: May 2, 2014
Last verified: May 2014
  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 Phase
Opioid Dependency
HIV Infections
Drug: Fosamprenavir/Ritonavir
Drug: Darunavir/Ritonavir
Drug: Rifampin
Drug: Rifabutin
Drug: Buprenorphine
Phase 1

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:


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

Primary Outcome Measures:
  • Effect of ARV or Tuberculosis Medication on Buprenorphine [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: April 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: May 2, 2014
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Buprenorphine
Darunavir
Fosamprenavir
Rifabutin
Rifampin
Ritonavir
Analgesics
Analgesics, Opioid
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on November 23, 2014