Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

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

Interventions

DRUG

Fosamprenavir/Ritonavir

1400/200 mg once daily for 15 days total

DRUG

Darunavir/Ritonavir

800/100 mg once daily for 15 days total

DRUG

Rifampin

600 mg once daily for 15 days total

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

Sponsors & Collaborators

• State University of New York at Buffalo

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Elinore F McCance-Katz, M.D., Ph.D. · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• United States

Study Locations