HIV InfectionsNCT00718029
Cerebrospinal Fluid (CSF) Raltegravir Substudy
An observational study of HIV Infections, run by University of California, San Diego.
Trial summary
The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid. The hypotheses are: Raltegravir concentrations in CSF will be measurable Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Feb 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.
Who may be able to join
- Enrollment in a raltegravir parent protocol at UCSD.
- Willing to undergo lumbar puncture.
- Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.
Who cannot join
- Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets<50,000/µL), hemophilia, or use of anticoagulant medication.
- Psychiatric disease that would interfere with study participation, in the opinion of the investigator.
- No major opportunistic infections within 30 days.
- Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.
About this study
Official title: MK: Raltegravir Concentrations in Cerebrospinal Fluid
The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.
The hypotheses are:
- Raltegravir concentrations in CSF will be measurable
- Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
- Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus, Cerebrospinal Fluid, Raltegravir, Drug Concentrations
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Scott L Letendre, MD, Principal investigator, University of California, San Diego AntiViral Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718029
- Sponsor's protocol ID
- MK: 33132
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2008
- Last updated
- 13 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MK: Raltegravir Concentrations in Cerebrospinal Fluid
- ClinicalTrials.gov ID
- NCT00718029
- Acronym / sponsor ID
- MK: 33132
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus, Cerebrospinal Fluid, Raltegravir, Drug Concentrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Jul 2008 (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 measure concentrations of Raltegravir in cerebrospinal fluid.
The hypotheses are:
- Raltegravir concentrations in CSF will be measurable
- Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
- Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.
Key inclusion criteria (3 listed)
- Enrollment in a raltegravir parent protocol at UCSD.
- Willing to undergo lumbar puncture.
- Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.
Key exclusion criteria (4 listed)
- Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets<50,000/µL), hemophilia, or use of anticoagulant medication.
- Psychiatric disease that would interfere with study participation, in the opinion of the investigator.
- No major opportunistic infections within 30 days.
- Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Aug 2019.
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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.
Scott L Letendre, MD principal investigator
University of California, San Diego AntiViral Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of California, San Diego.
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 3 inclusion and 4 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 Aug 2019.