Healthy VolunteersEarly Phase 1NCT01935830
LAAM-HAART PET Imaging
A Early Phase 1 study testing [11c] LAAM, Ritonavir and Efavirenz in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [11c] LAAM, Ritonavir and Efavirenz
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must meet all of the following criteria:
- Male or non-pregnant female volunteer, 18-50 yr old
- Good general health with no known major medical conditions
- BMI < 33
- Provide informed consent
Who cannot join
- Subjects will not be enrolled if any of the following criteria exist:
- Known history of liver or kidney disease
- History of major medical conditions
- HIV seropositive
- Fasting blood glucose > 110 mg/dl (because HAART can cause glucose intolerance)
- Family history of type 2 diabetes
Show all 11Show fewer
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A (hormonal birth control medications are acceptable if alternative means of contraception are used)
- Females who are pregnant or nursing
- Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
- Contraindications to MRI (e.g., metal implants or splinters in the body; a worn or implanted medical device, such as a pacemaker or drug pump; inability to lie flat for up to one hour; claustrophobia) or contraindications to PET scanning (e.g., inability to lie flat for up to one hour, claustrophobia, current
- Current or recent (within 12 months prior to screening) participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1))
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging
The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.
- Conditions
- Healthy Volunteers
- Being tested
- [11c] LAAM, Ritonavir, Efavirenz
- Keywords
- PET Imaging, Efavirenz, Ritonavior [11C] LAAM, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11c] LAAMRadiation
intravenous administration of 15-20 mCi of [11c] LAAM.
RitonavirDrug
Also called Kaletra
Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
EfavirenzDrug
Also called Sustiva, Atripla
Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
| Study group | Role | What they receive |
|---|---|---|
| LAAM arm | Experimental | 1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
2. Efavirenz, oral capsules, 600 mg
3. Ritonavir, oral capsules, 100 mg Receives: Radiation: [11c] LAAM; Drug: Ritonavir; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral [11C]LAAM distribution volume
Blood tests, MRI and PET data analysis and interpretation
Measured: approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan D Kharasch, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935830
- Sponsor's protocol ID
- 201307040
- Status last verified
- Dec 2017
- First submitted
- 30 Aug 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging
- ClinicalTrials.gov ID
- NCT01935830
- Acronym / sponsor ID
- 201307040
- Conditions
- Healthy Volunteers
- Keywords
- PET Imaging, Efavirenz, Ritonavior [11C] LAAM, Healthy volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAAM arm | Experimental | Radiation: [11c] LAAM, Drug: Ritonavir, Drug: Efavirenz1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug) 2. Efavirenz, oral capsules, 600 mg 3. Ritonavir, oral capsules, 100 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female volunteer, 18-50 yr old
- Good general health with no known major medical conditions
- BMI < 33
- Provide informed consent
Key exclusion criteria (11 listed)
- Known history of liver or kidney disease
- History of major medical conditions
- HIV seropositive
- Fasting blood glucose > 110 mg/dl (because HAART can cause glucose intolerance)
- Family history of type 2 diabetes
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 |
|---|---|---|
| [11c] LAAMintravenous administration of 15-20 mCi of [11c] LAAM. | Radiation | LAAM arm |
| RitonavirAlso: KaletraPretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM. | Drug | LAAM arm |
| EfavirenzAlso: Sustiva, AtriplaPretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM. | Drug | LAAM arm |
Primary outcome
cerebral [11C]LAAM distribution volume
Time frame: approximately 3 months
Blood tests, MRI and PET data analysis and interpretation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Evan D Kharasch, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [11c] LAAM, Ritonavir and Efavirenz in people with Healthy Volunteers, run by Washington University School of Medicine 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 5 inclusion and 11 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 13 Dec 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cerebral [11C]LAAM distribution volume (time frame: approximately 3 months). 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 13 Dec 2017.