HIVPhase 3NCT00887653
Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
A Phase 3 study testing raltegravir in people with HIV and Hyperlipidemia, run by The Miriam Hospital at 2 sites in United States.
Trial summary
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hyperlipidemia, Hypertriglyceridemia
- What is being tested?
- raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Apr 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Fasting LDL>130 mg/dL
- Fasting triglycerides >250 mg/dL
- Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
- No prior history of any NRTI resistance.
Who cannot join
- History of NRTI resistance mutations
- Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
- Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- Breast-feeding or pregnancy.
- Use of immunosuppressive medications within 60 days prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts University
Boston, Massachusetts, 02111
Miriam Hospital Immunology Clinic
Providence, Rhode Island, 02906
About this study
Official title: Changes in Lipid Profiles and Safety of Raltegravir Based Antiretroviral Therapy in HIV-1-infected Patients With Hyperlipidemia While on Current Standard Therapy
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.
The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited.
Read more
Hypotheses:
- Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
- Raltegravir will be safe and well tolerated.
- Raltegravir will have similar antiretroviral activity compared with the prior regimen.
Primary Objective:
To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.
Study Design: Subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the study for 6 months. At entry, the subjects will undergo a complete physical exam and thereafter targeted exams at each visit. Labs will be drawn as part of clinical care at 2, 3, and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be compared before and after the study. At the end of the study, the participants may choose to continue on raltegravir if they desire.
Read the detailed description
The success of combination antiretroviral therapy heralded a revolution in the management of patients with HIV in the mid-1990s. Increasingly, severe treatment-associated metabolic side effects have been observed and linked to premature coronary artery disease. This effect has been described among many regimens containing protease inhibitors (PIs) as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Raltegravir is a novel HIV-1 integrase inhibitor which in a comparison study with efavirenz has been shown to be potent and efficacious in suppression of the HIV-1. Minimal side effects were reported which mainly included nausea, headache, dizziness, diarrhea, and insomnia.
Hypotheses:
- Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
- Raltegravir will be safe and well tolerated.
- Raltegravir will have similar antiretroviral activity compared with the prior regimen.
Primary Objective:
To demonstrate an improvement in triglycerides or LDL in subjects switched to raltegravir from PIs or NNRTIs at 2 months, 3 months, and 6 months after study entry.
Secondary Objectives:
To assess the immunologic and virologic outcomes in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after entry.
Study Design:
This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Primary endpoint: Change from baseline LDL and change from baseline triglycerides at 3 months, adjusted for BMI and smoking status.
The subjects' plasma viral load before and after switching will be compared with a paired t test at each time point.
The subjects' CD4+ T cell count will be compared with a paired t test before and after switching.
- Conditions
- HIV, Hyperlipidemia, Hypertriglyceridemia, HIV Infections
- Being tested
- raltegravir
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia, 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
This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months Receives: Drug: raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Triglycerides
Assess changes from baseline triglycerides at 3 months
Measured: 3 months
Change From Baseline Triglycerides
Assess changes from baseline triglycerides at 6 months
Measured: 6 months
Secondary outcomes (1)
Proportion of Patients With Plasma Viral Load Below the Limit of Detection
Assess proportion of patients with PVL below limit of detection at end of study.
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 posted24 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionApr 2014
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Aadia Rana, The Miriam Hospital
- Investigators
- Karen Tashima, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887653
- Sponsor's protocol ID
- 2007-09
- Status last verified
- Oct 2014
- First submitted
- 23 Apr 2009
- Last updated
- 10 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Lipid Profiles and Safety of Raltegravir Based Antiretroviral Therapy in HIV-1-infected Patients With Hyperlipidemia While on Current Standard Therapy
- ClinicalTrials.gov ID
- NCT00887653
- Acronym / sponsor ID
- 2007-09
- Conditions
- HIV, Hyperlipidemia, Hypertriglyceridemia, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Merck Sharp & Dohme LLC
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 10 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.
The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited.
Hypotheses:
- Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
- Raltegravir will be safe and well tolerated.
- Raltegravir will have similar antiretroviral activity compared with the prior regimen.
Primary Objective:
To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.
Study Design: Subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the study for 6 months. At entry, the subjects will undergo a complete physical exam and thereafter targeted exams at each visit. Labs will be drawn as part of clinical care at 2, 3, and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be compared before and after the study. At the end of the study, the participants may choose to continue on raltegravir if they desire.
Detailed description
The success of combination antiretroviral therapy heralded a revolution in the management of patients with HIV in the mid-1990s. Increasingly, severe treatment-associated metabolic side effects have been observed and linked to premature coronary artery disease. This effect has been described among many regimens containing protease inhibitors (PIs) as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Raltegravir is a novel HIV-1 integrase inhibitor which in a comparison study with efavirenz has been shown to be potent and efficacious in suppression of the HIV-1. Minimal side effects were reported which mainly included nausea, headache, dizziness, diarrhea, and insomnia.
Hypotheses:
- Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
- Raltegravir will be safe and well tolerated.
- Raltegravir will have similar antiretroviral activity compared with the prior regimen.
Primary Objective:
To demonstrate an improvement in triglycerides or LDL in subjects switched to raltegravir from PIs or NNRTIs at 2 months, 3 months, and 6 months after study entry.
Secondary Objectives:
To assess the immunologic and virologic outcomes in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after entry.
Study Design:
This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Primary endpoint: Change from baseline LDL and change from baseline triglycerides at 3 months, adjusted for BMI and smoking status.
The subjects' plasma viral load before and after switching will be compared with a paired t test at each time point.
The subjects' CD4+ T cell count will be compared with a paired t test before and after switching.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: raltegravirThis is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18
- Fasting LDL>130 mg/dL
- Fasting triglycerides >250 mg/dL
- Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
- No prior history of any NRTI resistance.
Key exclusion criteria (6 listed)
- History of NRTI resistance mutations
- Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
- Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- Breast-feeding or pregnancy.
- Use of immunosuppressive medications within 60 days prior to 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: IsentressThis will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. | Drug | Raltegravir |
Primary outcome
Change From Baseline Triglycerides
Time frame: 3 months
Assess changes from baseline triglycerides at 3 months
Change From Baseline Triglycerides
Time frame: 6 months
Assess changes from baseline triglycerides at 6 months
1 secondary outcome
Proportion of Patients With Plasma Viral Load Below the Limit of Detection
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 10 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen Tashima, MD principal investigator
The Miriam Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing raltegravir in people with HIV and Hyperlipidemia, run by The Miriam Hospital at 2 sites 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 6 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 10 Oct 2014. 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 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Oct 2014). 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?
Change From Baseline Triglycerides (time frame: 3 months). 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?
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 10 Oct 2014.