Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

NCT00877591 | Completed Phase 1

• 1 other identifier: R01DA013004
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Opioid Dependency; HIV Infections

Keywords

Interaction of Buprenorphine with HIV and TB Medications

Outcome Measures

Primary Outcomes (1)

• Effect of ARV or Tuberculosis Medication on Buprenorphine

  2007-2010

Study Arms (6)

1

EXPERIMENTAL

Buprenorphine + Fosamprenavir/Ritonavir

Drug: Fosamprenavir/Ritonavir; Drug: Buprenorphine

2

ACTIVE COMPARATOR

Control Fosamprenavir/Ritonavir

Drug: Fosamprenavir/Ritonavir

3

EXPERIMENTAL

Buprenorphine + Darunavir/Ritonavir

Drug: Darunavir/Ritonavir; Drug: Buprenorphine

4

ACTIVE COMPARATOR

Control Darunavir/Ritonavir

Drug: Darunavir/Ritonavir

5

EXPERIMENTAL

Buprenorphine + Rifampin

Drug: Rifampin; Drug: Buprenorphine

6

EXPERIMENTAL

Buprenorphine + Rifabutin

Drug: Rifabutin; Drug: Buprenorphine

Interventions

Fosamprenavir/Ritonavir DRUG

1400/200 mg once daily for 15 days total

Also known as: Lexiva/Norvir

1; 2

Darunavir/Ritonavir DRUG

800/100 mg once daily for 15 days total

Also known as: Prezista/Norvir

3; 4

Rifampin DRUG

600 mg once daily for 15 days total

5

Rifabutin DRUG

300 mg once daily for 15 days total

6

Buprenorphine DRUG

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

Also known as: Suboxone

1; 3; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• State University of New York at Buffalo: collaborator
• University of Utah: collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

fosamprenavir; Ritonavir; Darunavir; Rifampin; Rifabutin; Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Furans; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Naloxone; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Elinore F McCance-Katz, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)