HIV InfectionsNCT00413153
Metabolic Effects of Switching Kaletra to Boosted Reyataz
A study testing atazanavir/ritonavir and lopinavir/ritonavir in people with HIV Infections, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- atazanavir/ritonavir and lopinavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2008
- 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
- Previously diagnosed HIV infection
- Age between 18-65 years
- Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- CD4 count > 400 cell/mm3
- Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.
Who cannot join
- Hemoglobin < 11.0 g/dL
- History of Diabetes Mellitus
- Currently on medication for Diabetes
- Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any contraindication to ATV/r or known allergy to ATV
Show all 9Show fewer
- Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
- New or serious opportunistic infection in the past 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.
Read the detailed description
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.
- Conditions
- HIV Infections
- Being tested
- atazanavir/ritonavir, lopinavir/ritonavir
- Keywords
- HIV, Kaletra, Reyataz, Insulin sensitivity, Lipids, Body Composition, Receiving Kaletra, Treatment Experienced
- Medical subject headings
- HIV Infections, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavir/ritonavirDrug
Also called Boosted Reyataz
atazanavir 300mg + ritonavir 100mg once daily
lopinavir/ritonavirDrug
Also called Kaletra
patient remains on their pre-study dose of lopinavir/ritonavir
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Boosted Reyataz (300mg atazanavir + 100mg ritonavir) Receives: Drug: atazanavir/ritonavir |
| 2 | Active comparator | Kaletra (pre-study dose) Receives: Drug: lopinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Trafficking
6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.
Measured: 6 months
Secondary outcomes (8)
Insulin Sensitivity
6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.
Measured: 6 months
Fasting Glucose
6 month mean and standard deviation for fasting glucose.
Measured: 6 months
Lipid Metabolism - Serum Triglyceride
6 month mean and standard deviation for serum triglyceride.
Measured: 6 months
Body Composition - Visceral Adipose Tissue
6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).
Measured: 6 months
Immune Parameters -- CD4 Count
6 month mean and standard deviation for CD4+ count.
Measured: 6 months
Liver Enzymes -- Aspartate Aminotransferase (AST)
6 month mean and standard deviation for AST.
Measured: 6 months
Liver Enzymes -- Alanine Aminotransferase (ALT)
6 month mean and standard deviation for ALT.
Measured: 6 months
Total Bilirubin
6 month mean and standard deviation for total bilirubin.
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 posted19 Dec 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Steven K Grinspoon, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413153
- Sponsor's protocol ID
- 2005-P-002239
- Status last verified
- Mar 2010
- First submitted
- 15 Dec 2006
- Last updated
- 9 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stanley TL, Joy T, Hadigan CM, Liebau JG, Makimura H, Chen CY, Thomas BJ, Weise SB, Robbins GK, Grinspoon SK. Effects of switching from lopinavir/ritonavir to atazanavir/ritonavir on muscle glucose uptake and visceral fat in HIV-infected patients. AIDS. 2009 Jul 17;23(11):1349-57. doi: 10.1097/QAD.0b013e32832ba904.
PubMed 19474651
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Switching Kaletra to Boosted Reyataz
- ClinicalTrials.gov ID
- NCT00413153
- Acronym / sponsor ID
- 2005-P-002239
- Conditions
- HIV Infections
- Keywords
- HIV, Kaletra, Reyataz, Insulin sensitivity, Lipids, Body Composition, Receiving Kaletra, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 3 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.
Detailed description
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: atazanavir/ritonavirBoosted Reyataz (300mg atazanavir + 100mg ritonavir) |
| 2 | Active comparator | Drug: lopinavir/ritonavirKaletra (pre-study dose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously diagnosed HIV infection
- Age between 18-65 years
- Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- CD4 count > 400 cell/mm3
- Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.
Key exclusion criteria (9 listed)
- Hemoglobin < 11.0 g/dL
- History of Diabetes Mellitus
- Currently on medication for Diabetes
- Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
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 |
|---|---|---|
| atazanavir/ritonavirAlso: Boosted Reyatazatazanavir 300mg + ritonavir 100mg once daily | Drug | 1 |
| lopinavir/ritonavirAlso: Kaletrapatient remains on their pre-study dose of lopinavir/ritonavir | Drug | 2 |
Primary outcome
Glucose Trafficking
Time frame: 6 months
6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.
8 secondary outcomes
Insulin Sensitivity
Time frame: 6 months
Fasting Glucose
Time frame: 6 months
Lipid Metabolism - Serum Triglyceride
Time frame: 6 months
Body Composition - Visceral Adipose Tissue
Time frame: 6 months
Immune Parameters -- CD4 Count
Time frame: 6 months
Liver Enzymes -- Aspartate Aminotransferase (AST)
Time frame: 6 months
Liver Enzymes -- Alanine Aminotransferase (ALT)
Time frame: 6 months
Total Bilirubin
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 9 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19474651Stanley TL, Joy T, Hadigan CM, Liebau JG, Makimura H, Chen CY, Thomas BJ, Weise SB, Robbins GK, Grinspoon SK. Effects of switching from lopinavir/ritonavir to atazanavir/ritonavir on muscle glucose uptake and visceral fat in HIV-infected patients. AIDS. 2009 Jul 17;23(11):1349-57. doi: 10.1097/QAD.0b013e32832ba904.
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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.
Steven K Grinspoon, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atazanavir/ritonavir and lopinavir/ritonavir in people with HIV Infections, run by Massachusetts General Hospital 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 5 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: finished, as of the sponsor's last update on 9 Mar 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 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 3 Mar 2010). 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?
Glucose Trafficking (time frame: 6 months). 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 NCT00413153, 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 9 Mar 2010.