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View Clinical Trial (Medical Research Study)
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Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications - NCT00877591-94110 (Clinical Trial 282981)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy282981.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94110 |
| Conditions: |
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Opioid Dependency - HIV Infections |
| Purpose: |
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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).
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| Study summary: |
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The overall objective of this project, RO1 DA 13004 "Opioids and HIV Medications:
Interactions in Drug Abusers" and the supplement "Interaction of Buprenorphine and TB
Medications," is to continue to improve the clinical care of human immunodeficiency virus
(HIV)-infected, substance-abusing patients by identifying significant interactions that may
occur between drugs commonly used to treat HIV disease or tuberculosis and buprenorphine,
the newest opioid used for maintenance treatment of opioid dependence and an important
addition to existing substance abuse pharmacotherapies because its use is not restricted to
specialized opiate treatment programs. The research funded by this grant over the past years
has shown the presence of significant and clinically important drug interactions between
methadone and LAAM in combination with antiretroviral medications. Understanding these drug
interactions will allow physicians to safely and more effectively treat HIV disease in
opioid-dependent patients. The following specific aims are yet to be completed for this
project which has another 2 years of a 5 year funding period: 1. Continuation of studies to
determine whether the pharmacokinetics of buprenorphine are affected by coadministration of
any of the following HIV medications fosamprenavir/ritonavir, darunavir or the TB
medications, rifampin or rifabutin. This will be done by comparing the pharmacokinetics of
buprenorphine in the absence and presence of each HIV medication using a within subjects
study design with participants who are opioid-dependent, without HIV infection, and
receiving medication maintenance treatment with buprenorphine/naloxone (please note that
naloxone absorption is negligible and is added to the buprenorphine preparation by the drug
manufacturer to diminish the likelihood of diversion of the drug to injected abuse). These
studies will allow an answer to a major question of concern to patients and their
clinicians: Could starting one of these HIV medications or TB medications result in opioid
overdose or withdrawal? These studies will determine whether buprenorphine accumulation and
toxicity might occur or whether buprenorphine concentrations at standard medication doses
will be subtherapeutic and/or expose the patient to the risk of opioid withdrawal symptoms
during conjoint HIV or TB therapy. 2. Continuation of studies to determine whether the
pharmacokinetics of the HIV medications fosamprenavir/ritonavir or darunavir, are affected
by coadministration of buprenorphine. This will be done in between-subjects studies by
comparing the pharmacokinetics of each HIV medication in groups of patients treated with
buprenorphine and in a control group without opioid dependence or HIV infection. It will be
important to identify any interaction leading to increased exposure to an HIV therapeutic
with a concomitant increase in side-effects and toxicities. In addition to unnecessary
discomfort and hazard, this may lead to non-adherence and/or increased substance abuse
particularly if side effects are interpreted as opioid withdrawal. Equally important,
substantial decreases in levels of HIV drugs could lead to subtherapeutic levels, inadequate
viral suppression, and the development of antiretroviral resistance and therapeutic failure.
(Please note that for the TB medications supplemental studies only the within-subjects
component with buprenorphine will be completed due to budgetary constraints of the
supplement.) Important clinical effects related to concomitant buprenorphine/HIV therapeutic
or TB medication administration are also collected including: 1. Measures of opioid
withdrawal symptoms will be collected prior to and following simultaneous
buprenorphine/antiretroviral administration 2. Measures of cognitive function will be
collected prior to and following simultaneous buprenorphine/antiretroviral administration 3.
Measures of the occurrence of adverse events will be systematically collected and chronicled
prior to and following simultaneous buprenorphine/antiretroviral administration 4. Effect of
buprenorphine alone and buprenorphine in combination with antiretroviral administration on
cardiac conduction will be obtained with serial electrocardiograms. 5. Effect of
buprenorphine alone and in combination with antiretroviral or anti-TB medication
administration on hepatic function through serial collection of laboratory blood tests of
liver function to gain insight into the potential of these drugs to produce hepatotoxicity.
The experimental protocol allows both sets of studies (Aims 1 and 2) to be accomplished
simultaneously in the same buprenorphine-maintained subjects, thereby achieving substantial
efficiencies in the current project. The studies offer a cost-effective method for rapid
determination of the presence and clinical significance of drug interactions between
buprenorphine and pharmacotherapies for infectious diseases of great clinical importance. |
| Criteria: |
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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. |
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| Study is available at: |
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San Francisco General Hospital
San Francisco, CA 94110
United States
Primary Contact:
Justine N Arenander, B.A.
Email: justine.arenander@ucsf.edu
Phone: (415) 206-5595 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
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