HIVPhase 4NCT01335620
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
A Phase 4 study testing Raltegravir, Tenofovir and Emtricitabine in people with HIV, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study. Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to: tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus raltegravir 400 mg twice daily On day 28, all subjects will attend… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Raltegravir, Tenofovir and Emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected males or females
- 60 years of age or greater*
- signed informed consent
- willing to switch therapy as per study protocol
- no previous exposure to raltegravir or HIV-1 integrase inhibitors
- plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
Show all 12Show fewer
- currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months
- no previous clinically-significant resistance documented on HIV-1 genotypic resistance
- subjects in good health upon medical history, physical exam, and laboratory testing
- BMI above or equal to 18 and below 32
- Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.
- Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance * 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.
Who cannot join
- current alcohol abuse or drug dependence
- positive urine drug of abuse screening
- active opportunistic infection or significant co-morbidities
- current disallowed concomitant medication
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chelsea & Westminster Hospital NHS Trust
London, SW10 9TH
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Read the detailed description
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.
At baseline, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.
Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
- Conditions
- HIV
- Being tested
- Raltegravir, Tenofovir, Emtricitabine
- Keywords
- HIV, Pharmatokinetic, 60 years old, Raltegravir
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 twice daily
TenofovirDrug
245 mg once daily
EmtricitabineDrug
200mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir/Emtricitabine and Raltegravir | Other | Single arm study
tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily Receives: Drug: Raltegravir; Drug: Tenofovir; Drug: Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Levels in Blood
rategravir concentration
Measured: Day 28
Changes in Haematology, Biochemistry and Virology Tests
full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus
Measured: 6 months
Secondary outcomes (2)
Cardiovascular Disease Markers
- To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.
Measured: 6 months
Cerebral Function; Changes in Global Cognitive Z-score
Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.
Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HIV affected over 60 years old
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MB BH, Principal investigator, Imperial College LondonMarta Boffito, Principal investigator, Chelsea & Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335620
- Sponsor's protocol ID
- RTG_60
- Other IDs
- 2010-022907-23
- Status last verified
- Oct 2019
- First submitted
- 25 Mar 2011
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vera JH, Jackson A, Dickinson L, Else L, Barber T, Mora-Peris B, Back D, Boffito M, Winston A. The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age. HIV Clin Trials. 2015 Jan-Feb;16(1):39-42. doi: 10.1179/1528433614Z.0000000006. Epub 2015 Jan 14.
PubMed 25777188
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
- ClinicalTrials.gov ID
- NCT01335620
- Acronym / sponsor ID
- RTG_60
- Conditions
- HIV
- Keywords
- HIV, Pharmatokinetic, 60 years old, Raltegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Detailed description
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.
At baseline, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.
Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HIV affected over 60 years old
| Arm | Type | Receives |
|---|---|---|
| Tenofovir/Emtricitabine and Raltegravir | Other | Drug: Raltegravir, Drug: Tenofovir, Drug: EmtricitabineSingle arm study tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- HIV-1 infected males or females
- 60 years of age or greater*
- signed informed consent
- willing to switch therapy as per study protocol
- no previous exposure to raltegravir or HIV-1 integrase inhibitors
Key exclusion criteria (4 listed)
- current alcohol abuse or drug dependence
- positive urine drug of abuse screening
- active opportunistic infection or significant co-morbidities
- current disallowed concomitant medication
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 twice daily | Drug | Tenofovir/Emtricitabine and Raltegravir |
| Tenofovir245 mg once daily | Drug | Tenofovir/Emtricitabine and Raltegravir |
| Emtricitabine200mg once daily | Drug | Tenofovir/Emtricitabine and Raltegravir |
Primary outcome
Drug Levels in Blood
Time frame: Day 28
rategravir concentration
Changes in Haematology, Biochemistry and Virology Tests
Time frame: 6 months
full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus
2 secondary outcomes
Cardiovascular Disease Markers
Time frame: 6 months
Cerebral Function; Changes in Global Cognitive Z-score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25777188Vera JH, Jackson A, Dickinson L, Else L, Barber T, Mora-Peris B, Back D, Boffito M, Winston A. The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age. HIV Clin Trials. 2015 Jan-Feb;16(1):39-42. doi: 10.1179/1528433614Z.0000000006. Epub 2015 Jan 14.
- 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.
Alan Winston, MB BH principal investigator
Imperial College London
Marta Boffito principal investigator
Chelsea & Westminster Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir, Tenofovir and Emtricitabine in people with HIV, run by Imperial College London at 2 sites in United Kingdom.
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 12 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 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?
Drug Levels in Blood (time frame: Day 28). The study lists 2 primary outcomes in all. 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 NCT01335620, which also lists 1 linked publication.
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 20 Nov 2019.