HIVNCT01293123

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

A study testing Raltegravir and Efavirenz in people with HIV, run by University of California, San Diego at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The primary aim of this study is to determine the effects of the HIV integrase inhibitor, raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before and after initiation of either raltegravir or another antiretroviral, efavirenz, each in combination with two other antiretrovirals. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV
What is being tested?: Raltegravir and Efavirenz
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Dec 2013
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women aged 18-65 years;
Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
Absolute T-cell CD4+ subset between 200-500/mm3
Individual willing to undergo serial lumbar punctures as outlined in study evaluations;
Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);
Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

Who cannot join

Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
Use of prescribed drugs with known substantial interactions with the study drugs;
Positive HCV serology;
HIV-associated dementia/Global Deterioration Scale ≥4;

Show all 9Show fewer

Pregnancy;
Serum creatinine higher than 2.0 mg/dL;
Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSD Antiviral Research Center
San Diego, California, 92103

Other trials in United States

About this study

Read the detailed description

Cognitive disorders continue to be a common complication of HIV disease even though potent antiretroviral drugs can reduce HIV below detectable levels and restore immune function. Concentrations of most antiretrovirals in the nervous system are only a fraction of concentrations in blood. As a result, HIV can continue to be present in the nervous system when it is below detection in blood. A recently approved drug, raltegravir, reaches therapeutic concentrations in cerebrospinal fluid and may be effective at controlling HIV replication in the primary target cells in the brain, macrophages and microglia. Based on this, raltegravir may be a particularly effective drug for treating HIV disease in the nervous system. The purpose of this study is to determine the effects of raltegravir in the nervous system by measuring HIV in the CSF (via lumbar puncture, also known as spinal taps) before and after initiation of raltegravir-containing antiretroviral therapy. CSF is an accessible fluid that provides a window into brain processes, including HIV replication and inflammation. The potency of raltegravir will be estimated by calculating the change in HIV viral load in CSF over time. These changes will be compared to those following initiation an efavirenz-containing regimen in a separate group of individuals. Two additional drugs (tenofovir disoproxil fumarate, emtricitabine) will be combined with either raltegravir or efavirenz. Neuropsychological performance, mood, sleep and quality of life assessment will also be compared. Participants will be randomly assigned to either raltegravir- or efavirenz-containing therapy.

Conditions: HIV
Being tested: Raltegravir, Efavirenz
Keywords: HIV, raltegravir, cerebrospinal fluid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RaltegravirDrug
Also called tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once daily
raltegravir 400 mg PO twice daily
EfavirenzDrug
Also called tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once daily
efavirenz 600 mg PO once daily

Study groups in NCT01293123
Study group	Role	What they receive
Raltegravir	Experimental	Not described Receives: Drug: Raltegravir
Efavirenz	Active comparator	Not described Receives: Drug: Efavirenz

What is being measured

The primary outcome is the main question the study is designed to answer.

Cerebrospinal Fluid HIV RNA Levels
Slope of decline of HIV RNA levels in CSF over time
Measured: 180 days

Secondary outcomes (4)

Neuropsychological Performance
Change in neuropsychological performance over 180 days
Measured: 180 days
Measure of Mood
Change in mood over 180 days
Measured: 180 days
Measure of Sleep
Change in self-reported sleep performance over 180 days.
Measured: 180 days
Measure of Quality of Life
Change in self-report quality of life over 180 days
Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Dec 2013

First posted10 Feb 2011 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionDec 2013

Why it stopped: Did not meet enrollment goals

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 HIVStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01293123
Sponsor's protocol ID: 11-0067
Status last verified: Oct 2019
First submitted: 9 Feb 2011
Last updated: 31 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals
ClinicalTrials.gov ID: NCT01293123
Acronym / sponsor ID: 11-0067
Conditions: HIV
Keywords: HIV, raltegravir, cerebrospinal fluid
Study type: Interventional
Recruitment status: TerminatedReason stopped: Did not meet enrollment goals
Enrolment: 2 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 10 Feb 2011 (estimated)
Results: Posted 31 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Raltegravir	Experimental	Drug: Raltegravir
Efavirenz	Active comparator	Drug: Efavirenz

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men and women aged 18-65 years;
Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
Absolute T-cell CD4+ subset between 200-500/mm3
Individual willing to undergo serial lumbar punctures as outlined in study evaluations;

Key exclusion criteria (9 listed)

Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
Use of prescribed drugs with known substantial interactions with the study drugs;
Positive HCV serology;

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: tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once dailyraltegravir 400 mg PO twice daily	Drug	Raltegravir
EfavirenzAlso: tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once dailyefavirenz 600 mg PO once daily	Drug	Efavirenz

Primary outcome

Cerebrospinal Fluid HIV RNA Levels
Time frame: 180 days
Slope of decline of HIV RNA levels in CSF over time

4 secondary outcomes

Neuropsychological Performance
Time frame: 180 days
Measure of Mood
Time frame: 180 days
Measure of Sleep
Time frame: 180 days
Measure of Quality of Life
Time frame: 180 days

Results and safety

Results posted to the registry on 31 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raltegravir	1	1
Efavirenz	1	0

Primary outcome: Cerebrospinal Fluid HIV RNA Levels

Time frame: 180 days

Population analysed: Insufficient enrollment for data analysis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Efavirenz	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Insufficient enrollment for data analysis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for HIV

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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 Letendre, MD principal investigator

University of California, San Diego

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 and Efavirenz in people with HIV, run by University of California, San Diego 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 31 Oct 2019. 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 31 Oct 2019). 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?

Cerebrospinal Fluid HIV RNA Levels (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01293123.

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 31 Oct 2019.