HIV InfectionNCT00858962
Buprenorphine/Raltegravir Pharmacokinetic Interaction Study
A study testing Raltegravir in people with HIV Infection and HIV Infections, run by Yale University at 1 site in United States.
Trial summary
The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- Raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are opioid dependent on long-term buprenorphine/naloxone (BUP/NLX) maintenance (minimum of 4 weeks) and who must remain at a stable dose of buprenorphine for at least 3 weeks deemed by the investigator to have acceptable medical history, physical examination and clinical laboratory evaluations consistent with BUP maintenance will be eligible to participate in the study.
- Body weight >60 kg for males and >40 kg for females
- Male or females, ages > 21 to < 60 years.
- Women of childbearing potential (WOCBP) must not be nursing or pregnant and must be on adequate non-hormonal contraception to avoid pregnancy. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Study Day 1.
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks before and after the study.
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of enrollment and throughout the study.
- Women who are currently pregnant or breastfeeding.
- History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
- Proven or suspected acute hepatitis at the time of study entry
- Any major surgery within 4 weeks of enrollment. Minor surgical procedures requiring local anesthesia are exceptions.
Show all 24Show fewer
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
- Blood transfusion within 4 weeks of enrollment.
- Inability to tolerate oral medication.
- Inability to tolerate venipuncture and/or absence of secure venous access.
- Inability to refrain from smoking during in-residence period
- Evidence of organ dysfunction or any clinically relevant (as determined by the investigator) deviations from the norms observed in a buprenorphine/naloxone treated population in physical examination, vital signs, or clinical laboratory determinations.
- Positive breathalyzer alcohol test, or positive urine screen for barbiturates, benzodiazepines, amphetamines, cocaine or opioids other than buprenorphine/naloxone.
- Subjects with AST, ALT or bilirubin > 3.0X the upper limit of normal
- Hemoglobin < 9 g/dL, and platelet count < 75,000/mm3.
- Positive serum or urine for HCG.
- History of any significant drug allergy, drug rash or sensitivity to any class of drugs relevant to the study drugs.
- HIV antibody positive
- Exposure to any investigational drug within 4 weeks of enrollment and throughout the study.
- Prior exposure to Raltegravir.
- Use of any agent (prescribed or otherwise) within 2 weeks of dosing, that is known or suspected to induce or inhibit drug metabolizing enzymes (e.g., cimetidine and compounds in the barbiturate and phenothiazine classes), affect renal tubular secretion (e.g., probenecid, beta-lactam antibiotics), gastrointestinal motility (e.g., metoclopramide, propantheline, loperamide, or narcotic analgesics or opioids other than buprenorphine/naloxone), or uric acid metabolism (e.g., allopurinol) or gastrointestinal pH (including antacids, H2-receptor antagonists, proton pump inhibitors etc.).
- Use of over-the-counter medications and herbal preparations, within 1 week prior to enrollment and throughout the study.
- Use of St. John's Wort (Hypericum) within four weeks prior to study enrollment and throughout the study.
- Consumption of grapefruit or grapefruit juice within 1 week of study entry and throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Raltegravir (Isentress) and Buprenorphine
The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. This will be determined by giving Raltegravir along with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood. The investigators will also learn about the effects of Buprenorphine on Raltegravir and about the safety of taking these two medications together.
Read the detailed description
A large number of people who are infected with HIV have acquired it through injection drug use. Some of these people are currently being treated with Buprenorphine for their addiction and with medications for HIV infection. Raltegravir is a medication that was approved by the Food and Drug Administration (FDA) for the treatment of HIV infection. Raltegravir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system in someone who is HIV infected.
Earlier studies looking at the effect of Buprenorphine and HIV medications have shown that Buprenorphine and some HIV medications act differently when taken together. It is important to learn if taking Buprenorphine and HIV medications together results in changes in the blood level of either medication. If the HIV medication affects the level of Buprenorphine in the blood, an individual taking Buprenorphine and HIV medications may experience symptoms of withdrawal, even while taking their usual dose of Buprenorphine. On the other hand, if Buprenorphine decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if Raltegravir and Buprenorphine will affect each other when taken together.
In order to learn about the effects of Buprenorphine and Raltegravir, we will need to measure the amount of Buprenorphine in your blood for 24 hours before you have taken Raltegravir and then compare that to the amount of Buprenorphine in your blood after you have taken Buprenorphine and Raltegravir together .
- Conditions
- HIV Infection, HIV Infections
- Being tested
- Raltegravir
- Keywords
- HIV, Pharmacokinetics, Pharmacodynamics, Buprenorphine, Raltegravir, HIV seronegativity, Interaction
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Bup/Ral | Experimental | Buprenorphine and Raltegravir co-administration Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)
PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.
Measured: 6-14 days after beginning co-administration of drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, R. Douglas Bruce, MD, MA, Yale University
- Investigators
- Robert D Bruce, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858962
- Sponsor's protocol ID
- 0811004456
- Other IDs
- R01DA025932
- Status last verified
- Oct 2012
- First submitted
- 6 Mar 2009
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Raltegravir (Isentress) and Buprenorphine
- ClinicalTrials.gov ID
- NCT00858962
- Acronym / sponsor ID
- 0811004456
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV, Pharmacokinetics, Pharmacodynamics, Buprenorphine, Raltegravir, HIV seronegativity, Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Merck Sharp & Dohme LLC
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. This will be determined by giving Raltegravir along with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood. The investigators will also learn about the effects of Buprenorphine on Raltegravir and about the safety of taking these two medications together.
Detailed description
A large number of people who are infected with HIV have acquired it through injection drug use. Some of these people are currently being treated with Buprenorphine for their addiction and with medications for HIV infection. Raltegravir is a medication that was approved by the Food and Drug Administration (FDA) for the treatment of HIV infection. Raltegravir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system in someone who is HIV infected.
Earlier studies looking at the effect of Buprenorphine and HIV medications have shown that Buprenorphine and some HIV medications act differently when taken together. It is important to learn if taking Buprenorphine and HIV medications together results in changes in the blood level of either medication. If the HIV medication affects the level of Buprenorphine in the blood, an individual taking Buprenorphine and HIV medications may experience symptoms of withdrawal, even while taking their usual dose of Buprenorphine. On the other hand, if Buprenorphine decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if Raltegravir and Buprenorphine will affect each other when taken together.
In order to learn about the effects of Buprenorphine and Raltegravir, we will need to measure the amount of Buprenorphine in your blood for 24 hours before you have taken Raltegravir and then compare that to the amount of Buprenorphine in your blood after you have taken Buprenorphine and Raltegravir together .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bup/Ral | Experimental | Drug: RaltegravirBuprenorphine and Raltegravir co-administration |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are opioid dependent on long-term buprenorphine/naloxone (BUP/NLX) maintenance (minimum of 4 weeks) and who must remain at a stable dose of buprenorphine for at least 3 weeks deemed by the investigator to have acceptable medical history, physical examination and clinical laboratory evaluations consistent with BUP maintenance will be eligible to participate in the study.
- Body weight >60 kg for males and >40 kg for females
- Male or females, ages > 21 to < 60 years.
- Women of childbearing potential (WOCBP) must not be nursing or pregnant and must be on adequate non-hormonal contraception to avoid pregnancy. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Study Day 1.
Key exclusion criteria (24 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks before and after the study.
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of enrollment and throughout the study.
- Women who are currently pregnant or breastfeeding.
- History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
- Proven or suspected acute hepatitis at the time of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirAlso: Isentress400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days. | Drug | Bup/Ral |
Primary outcome
Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)
Time frame: 6-14 days after beginning co-administration of drugs
PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV Infection
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Bruce, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raltegravir in people with HIV Infection and HIV Infections, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL) (time frame: 6-14 days after beginning co-administration of drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.