HIV InfectionsPhase 1NCT00531999
Raltegravir Insulin Sensitivity Study
A Phase 1 study testing Raltegravir then lopinavir/ritonavir and Lopinavir/ritonavir then raltegravir in people with HIV Infections, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
The purpose of the study is to look at the effects of two different HIV medications on the body's response to insulin (a hormone that regulates blood sugar levels). This will be done using a method called the 'euglycaemic clamp' The study will also investigate the effects of these drugs on blood fats and on… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir then lopinavir/ritonavir and Lopinavir/ritonavir then raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Aug 2008
- Phase
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have documented negative HIV serology by ELISA and P24 antigen
- Subjects must be clinically well males aged between 18 to 60 years
- Fasting blood glucose, total cholesterol and triglycerides within normal limits
- Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
- Serum amylase ≤ 1.5 × ULN (subjects with serum amylase > 1.5 × ULN will remain eligible if pancreatic lipase is ≤ 1.5 × ULN)
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- Sexually active males must use condoms during the course of the study
- Life expectancy ≥ 1 year
- Willing and able to provide informed consent
Who cannot join
- Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension
- Receiving on-going therapy with any of the following:
- Metabolically active medications
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- Any lipid-lowering medication
- Hormonal agents (oestrogens or androgens)
- Glucocorticoids
- Beta-blockers
- Thiazide diuretics
- Thyroid preparations
- Psychotropic agents
- Anabolic steroids
- Megestrol acetate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Stephens Centre, Chelsea & Westminster Hospital
London
About this study
Official title: An Open Label Study of the Impact on Insulin Sensitivity, Lipid Profile and Vascular Inflammation by Treatment With Lopinavir / Ritonavir (400 / 100 mg Twice Daily) or Raltegravir 400 mg Twice Daily in HIV Negative Male Volunteers.
The purpose of the study is to look at the effects of two different HIV medications on the body's response to insulin (a hormone that regulates blood sugar levels). This will be done using a method called the 'euglycaemic clamp'
The study will also investigate the effects of these drugs on blood fats and on circulating markers in the blood stream related to blood vessels (vascular inflammation markers).
Read the detailed description
Subjects will undergo four euglycaemic clamp procedures in order to determine the extent of glucose disposal. The first clamp will be performed prior to the commencement of the first study drug administration, the second one following two weeks of study drug, the third after a two week washout period, prior to commencement of second study drug administration and the fourth after two weeks of the second study drug
- Conditions
- HIV Infections
- Being tested
- Raltegravir then lopinavir/ritonavir, Lopinavir/ritonavir then raltegravir
- Keywords
- Raltegravir, Euglycaemic clamp, healthy volunteer
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir then lopinavir/ritonavirDrug
raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study
Lopinavir/ritonavir then raltegravirDrug
lopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Raltegravir 400 mg twice daily for the first 14 days of the study. Lopinavir/ritonavir 400/100 mg twice daily for the last 14 days of the study Receives: Drug: Raltegravir then lopinavir/ritonavir |
| 2 | Active comparator | * Lopinavir/ritonavir 400/100 mg twice daily for the first 14 days of the study.
* Raltegravir 400 mg twice daily for the last 14 days of the study. Receives: Drug: Lopinavir/ritonavir then raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in insulin sensitivity by euglycaemic clamp method
Measured: 2 weeks
Secondary outcomes (1)
Change from baseline in serum levels of fasting cholesterol, triglycerides
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Investigators
- Greame Moyle, Principal investigator, Chelsea & Westminser Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531999
- Sponsor's protocol ID
- SSAT023
- Status last verified
- Aug 2010
- First submitted
- 18 Sep 2007
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Impact on Insulin Sensitivity, Lipid Profile and Vascular Inflammation by Treatment With Lopinavir / Ritonavir (400 / 100 mg Twice Daily) or Raltegravir 400 mg Twice Daily in HIV Negative Male Volunteers.
- ClinicalTrials.gov ID
- NCT00531999
- Acronym / sponsor ID
- SSAT023
- Conditions
- HIV Infections
- Keywords
- Raltegravir, Euglycaemic clamp, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Sep 2007 (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 the study is to look at the effects of two different HIV medications on the body's response to insulin (a hormone that regulates blood sugar levels). This will be done using a method called the 'euglycaemic clamp'
The study will also investigate the effects of these drugs on blood fats and on circulating markers in the blood stream related to blood vessels (vascular inflammation markers).
Detailed description
Subjects will undergo four euglycaemic clamp procedures in order to determine the extent of glucose disposal. The first clamp will be performed prior to the commencement of the first study drug administration, the second one following two weeks of study drug, the third after a two week washout period, prior to commencement of second study drug administration and the fourth after two weeks of the second study drug
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Raltegravir then lopinavir/ritonavirRaltegravir 400 mg twice daily for the first 14 days of the study. Lopinavir/ritonavir 400/100 mg twice daily for the last 14 days of the study |
| 2 | Active comparator | Drug: Lopinavir/ritonavir then raltegravir* Lopinavir/ritonavir 400/100 mg twice daily for the first 14 days of the study. * Raltegravir 400 mg twice daily for the last 14 days of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must have documented negative HIV serology by ELISA and P24 antigen
- Subjects must be clinically well males aged between 18 to 60 years
- Fasting blood glucose, total cholesterol and triglycerides within normal limits
- Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
Key exclusion criteria (15 listed)
- Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension
- Receiving on-going therapy with any of the following:
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 |
|---|---|---|
| Raltegravir then lopinavir/ritonavirraltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study | Drug | 1 |
| Lopinavir/ritonavir then raltegravirlopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study | Drug | 2 |
Primary outcome
Change from baseline in insulin sensitivity by euglycaemic clamp method
Time frame: 2 weeks
1 secondary outcome
Change from baseline in serum levels of fasting cholesterol, triglycerides
Time frame: 2 weeks
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 16 Aug 2010.
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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.
Greame Moyle principal investigator
Chelsea & Westminser Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raltegravir then lopinavir/ritonavir and Lopinavir/ritonavir then raltegravir in people with HIV Infections, run by St Stephens Aids Trust at 1 site 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 9 inclusion and 15 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 16 Aug 2010. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline in insulin sensitivity by euglycaemic clamp method (time frame: 2 weeks). 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 16 Aug 2010.