Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications
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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 |
- Pharmacokinetics of Buprenorphine with Coadministration of HIV or TB Medications [ Time Frame: 09/07-09/09 ] [ Designated as safety issue: No ]
- 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: | October 2013 |
| Estimated Primary Completion Date: | October 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 |
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| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
| 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: | October 17, 2012 |
| 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 March 03, 2013
