HIV InfectionsNCT00525239
HIV Antiretroviral Drugs and Metabolism
A study testing ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz in people with HIV Infections, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Hypothesis 1: Ritonavir-based regimens increase triglycerides and VLDL by both increasing VLDL production and decreasing VLDL clearance. Specific Aim 1A: To quantify the effect of ritonavir on VLDL production and clearance using stable isotope turnover and other clearance methods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Protocols 1, 2A and 3 HIV negative, healthy normal volunteers, age > 18 years old.
- Protocol 2B HIV-infected subjects, age > 18 years old and documented to have HIV-1 infection for ≥ 6 months, being started on efavirenz by their health care provider.
Who cannot join
- Protocols 1, 2A and 3 Coronary artery disease, peripheral vascular disease, impaired fasting glucose (glucose > 100 mg/dl), obese (BMI > 30), dyslipidemia (triglycerides > 190 mg/dl, LDL-C > 190), anemia (Hct < 39), hypertension (BP> 140/90 mmHg or on medication), blood pressure <100 mmHg, renal disease (creatinine > 1.6), LFT > ULN, or use within 30 days of systemic glucocorticoids, anabolic steroids, growth hormone, niacin, antipsychotics, or lipid lowering medications. Women will be tested for pregnancy immediately prior to each inpatient study and excluded if pregnant. For Specific Aim 2, additional exclusion criteria include history of depression requiring treatment, psychosis, hallucinations or delusions; use of cGMP specific phosphodiesterase 5 inhibitors (e.g., sildenafil) within 7 days of study; or history of adverse reaction to nitrates.
- Protocols 1, 2A and 3 Currently on an NNRTI, coronary artery disease, peripheral vascular disease, recent opportunistic infection (within two months), impaired fasting glucose (glucose > 100 mg/dl) or diabetes, anemia (Hct < 39), hypertension (BP > 140/90 mmHg or on medication), blood pressure <100 mmHg, renal disease (Creatinine > 1.6), LFT > 2x ULN, use of cGMP specific phosphodiesterase 5 inhibitors (e.g., sildenafil) within 7 days of study, history of adverse reaction to nitrates, use within 30 days of anabolic steroids, systemic glucocorticoids, growth hormone, niacin, antipsychotics, or lipid lowering medications. Women will be tested for pregnancy immediately prior to each inpatient study and excluded if pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Veterans Affairs Medical Center
San Francisco, California, 94121
Mae Pang, RN, MSN, 415-750-2005, miyin.pang@ucsf.edu
Lyda Galvez, 415-750-2005, lyda.galvez@va.gov
About this study
Hypothesis 1: Ritonavir-based regimens increase triglycerides and VLDL by both increasing VLDL production and decreasing VLDL clearance.
Specific Aim 1A: To quantify the effect of ritonavir on VLDL production and clearance using stable isotope turnover and other clearance methods.
Read more
Specific Aim 1B: To determine the composition of the triglyceride rich particles.
Protocol 1: The effects of ritonavir-based regimens on VLDL production, VLDL clearance and triglyceride-rich lipoprotein composition in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.
Hypothesis 2: NNRTI drugs do not increase HDL by increasing apo AI production, but rather by decreasing apo AI clearance, prolonging time in circulation.
Specific Aim 2A: To determine the composition of HDL before and after NNRTI and assess its function.
Specific Aim 2B: To quantify the effect of NNRTI on apo AI production and clearance using stable isotopes.
Specific Aim 2C: To determine if the NNRTI induced increase in HDL is accompanied by improvement in flow mediated vasodilation and circulating markers of endothelial function Protocol 2A: The effects of efavirenz on HDL composition, HDL function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating markers of endothelial dysfunction in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of six weeks of taking efavirenz.
Protocol 2B: The effects of starting an efavirenz-based regimen on HDL composition, HDL function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating markers of endothelial dysfunction in patients with HIV infection. HIV-infected patients whose care providers have prescribed an efavirenz-based regimen will be studied before and after six weeks of starting efavirenz.
Hypothesis 3: Ritonavir-based PI regimens impair insulin secretion. Specific Aim 3: To determine which ritonavir-based PI regimens alter insulin secretion.
Protocol 3: The effects of ritonavir-based regimens on insulin secretion in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.
- Conditions
- HIV Infections
- Being tested
- ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz
- Keywords
- Lipids, lipoproteins, VLDL, triglycerides, apo B100, HDL, apo A1, endothelial dysfunction, insulin secretion, hyperglycemic clamp, HIV-seronegative Volunteers, HIV-infected subjects starting an efavirenz-based regimen, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenzDrug
100 mg, twice daily, for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 1: Ritonaivr | Experimental | Pre and post ritonavir, lopinavir/ritonavir or atazanavir/ritonavir Receives: Drug: ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of HIV Protease Inhibitors on Glucose Metabolism by Hyperglycemic Clamp
Measured: 4 weeks
Secondary outcomes (1)
Effect of HIV Protease Inhibitors on Oral Glucose Tolerance Test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startMar 2004
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Carl Grunfeld, M.D., Ph.D., Principal investigator, Northern California Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525239
- Sponsor's protocol ID
- DK66999
- Status last verified
- Mar 2011
- First submitted
- 4 Sep 2007
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noor MA, Lo JC, Mulligan K, Schwarz JM, Halvorsen RA, Schambelan M, Grunfeld C. Metabolic effects of indinavir in healthy HIV-seronegative men. AIDS. 2001 May 4;15(7):F11-8. doi: 10.1097/00002030-200105040-00001.
PubMed 11399973Noor MA, Seneviratne T, Aweeka FT, Lo JC, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Indinavir acutely inhibits insulin-stimulated glucose disposal in humans: a randomized, placebo-controlled study. AIDS. 2002 Mar 29;16(5):F1-8. doi: 10.1097/00002030-200203290-00002.
PubMed 11964551Lee GA, Seneviratne T, Noor MA, Lo JC, Schwarz JM, Aweeka FT, Mulligan K, Schambelan M, Grunfeld C. The metabolic effects of lopinavir/ritonavir in HIV-negative men. AIDS. 2004 Mar 5;18(4):641-9. doi: 10.1097/00002030-200403050-00008.
PubMed 15090769Lee GA, Mafong DD, Noor MA, Lo JC, Mulligan K, Schwarz JM, Schambelan M, Grunfeld C. HIV protease inhibitors increase adiponectin levels in HIV-negative men. J Acquir Immune Defic Syndr. 2004 May 1;36(1):645-7. doi: 10.1097/00126334-200405010-00017. No abstract available.
PubMed 15097312Schwarz JM, Lee GA, Park S, Noor MA, Lee J, Wen M, Lo JC, Mulligan K, Schambelan M, Grunfeld C. Indinavir increases glucose production in healthy HIV-negative men. AIDS. 2004 Sep 3;18(13):1852-4. doi: 10.1097/00002030-200409030-00017.
PubMed 15316349Lee GA, Rao MN, Grunfeld C. The effects of HIV protease inhibitors on carbohydrate and lipid metabolism. Curr HIV/AIDS Rep. 2005 Feb;2(1):39-50. doi: 10.1007/s11904-996-0008-z.
PubMed 16091248Lee GA, Lo JC, Aweeka F, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Single-dose lopinavir-ritonavir acutely inhibits insulin-mediated glucose disposal in healthy volunteers. Clin Infect Dis. 2006 Sep 1;43(5):658-60. doi: 10.1086/505974. Epub 2006 Jul 26.
PubMed 16886163Lee GA, Rao M, Mulligan K, Lo JC, Aweeka F, Schwarz JM, Schambelan M, Grunfeld C. Effects of ritonavir and amprenavir on insulin sensitivity in healthy volunteers. AIDS. 2007 Oct 18;21(16):2183-90. doi: 10.1097/QAD.0b013e32826fbc54.
PubMed 18090045Taylor SA, Lee GA, Pao VY, Anthonypillai J, Aweeka FT, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Boosting dose ritonavir does not alter peripheral insulin sensitivity in healthy HIV-seronegative volunteers. J Acquir Immune Defic Syndr. 2010 Nov;55(3):361-4. doi: 10.1097/QAI.0b013e3181e6a7d9.
PubMed 20595906Pao VY, Lee GA, Taylor S, Aweeka FT, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. The protease inhibitor combination lopinavir/ritonavir does not decrease insulin secretion in healthy, HIV-seronegative volunteers. AIDS. 2010 Jan 16;24(2):265-70. doi: 10.1097/QAD.0b013e328333af1c.
PubMed 19890203
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Antiretroviral Drugs and Metabolism
- ClinicalTrials.gov ID
- NCT00525239
- Acronym / sponsor ID
- DK66999
- Conditions
- HIV Infections
- Keywords
- Lipids, lipoproteins, VLDL, triglycerides, apo B100, HDL, apo A1, endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 2004
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 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.
Hypothesis 1: Ritonavir-based regimens increase triglycerides and VLDL by both increasing VLDL production and decreasing VLDL clearance.
Specific Aim 1A: To quantify the effect of ritonavir on VLDL production and clearance using stable isotope turnover and other clearance methods.
Specific Aim 1B: To determine the composition of the triglyceride rich particles.
Protocol 1: The effects of ritonavir-based regimens on VLDL production, VLDL clearance and triglyceride-rich lipoprotein composition in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.
Hypothesis 2: NNRTI drugs do not increase HDL by increasing apo AI production, but rather by decreasing apo AI clearance, prolonging time in circulation.
Specific Aim 2A: To determine the composition of HDL before and after NNRTI and assess its function.
Specific Aim 2B: To quantify the effect of NNRTI on apo AI production and clearance using stable isotopes.
Specific Aim 2C: To determine if the NNRTI induced increase in HDL is accompanied by improvement in flow mediated vasodilation and circulating markers of endothelial function Protocol 2A: The effects of efavirenz on HDL composition, HDL function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating markers of endothelial dysfunction in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of six weeks of taking efavirenz.
Protocol 2B: The effects of starting an efavirenz-based regimen on HDL composition, HDL function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating markers of endothelial dysfunction in patients with HIV infection. HIV-infected patients whose care providers have prescribed an efavirenz-based regimen will be studied before and after six weeks of starting efavirenz.
Hypothesis 3: Ritonavir-based PI regimens impair insulin secretion. Specific Aim 3: To determine which ritonavir-based PI regimens alter insulin secretion.
Protocol 3: The effects of ritonavir-based regimens on insulin secretion in healthy normal volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Ritonaivr | Experimental | Drug: ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenzPre and post ritonavir, lopinavir/ritonavir or atazanavir/ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Protocols 1, 2A and 3 HIV negative, healthy normal volunteers, age > 18 years old.
- Protocol 2B HIV-infected subjects, age > 18 years old and documented to have HIV-1 infection for ≥ 6 months, being started on efavirenz by their health care provider.
Key exclusion criteria (2 listed)
- Protocols 1, 2A and 3 Coronary artery disease, peripheral vascular disease, impaired fasting glucose (glucose > 100 mg/dl), obese (BMI > 30), dyslipidemia (triglycerides > 190 mg/dl, LDL-C > 190), anemia (Hct < 39), hypertension (BP> 140/90 mmHg or on medication), blood pressure <100 mmHg, renal disease (creatinine > 1.6), LFT > ULN, or use within 30 days of systemic glucocorticoids, anabolic steroids, growth hormone, niacin, antipsychotics, or lipid lowering medications. Women will be tested for pregnancy immediately prior to each inpatient study and excluded if pregnant. For Specific Aim 2, additional exclusion criteria include history of depression requiring treatment, psychosis, hallucinations or delusions; use of cGMP specific phosphodiesterase 5 inhibitors (e.g., sildenafil) within 7 days of study; or history of adverse reaction to nitrates.
- Protocols 1, 2A and 3 Currently on an NNRTI, coronary artery disease, peripheral vascular disease, recent opportunistic infection (within two months), impaired fasting glucose (glucose > 100 mg/dl) or diabetes, anemia (Hct < 39), hypertension (BP > 140/90 mmHg or on medication), blood pressure <100 mmHg, renal disease (Creatinine > 1.6), LFT > 2x ULN, use of cGMP specific phosphodiesterase 5 inhibitors (e.g., sildenafil) within 7 days of study, history of adverse reaction to nitrates, use within 30 days of anabolic steroids, systemic glucocorticoids, growth hormone, niacin, antipsychotics, or lipid lowering medications. Women will be tested for pregnancy immediately prior to each inpatient study and excluded if pregnant
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 |
|---|---|---|
| ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz100 mg, twice daily, for four weeks | Drug | 1: Ritonaivr |
Primary outcome
Effect of HIV Protease Inhibitors on Glucose Metabolism by Hyperglycemic Clamp
Time frame: 4 weeks
1 secondary outcome
Effect of HIV Protease Inhibitors on Oral Glucose Tolerance Test
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Results publication: PubMed 11399973Noor MA, Lo JC, Mulligan K, Schwarz JM, Halvorsen RA, Schambelan M, Grunfeld C. Metabolic effects of indinavir in healthy HIV-seronegative men. AIDS. 2001 May 4;15(7):F11-8. doi: 10.1097/00002030-200105040-00001.
- Results publication: PubMed 11964551Noor MA, Seneviratne T, Aweeka FT, Lo JC, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Indinavir acutely inhibits insulin-stimulated glucose disposal in humans: a randomized, placebo-controlled study. AIDS. 2002 Mar 29;16(5):F1-8. doi: 10.1097/00002030-200203290-00002.
- Results publication: PubMed 15090769Lee GA, Seneviratne T, Noor MA, Lo JC, Schwarz JM, Aweeka FT, Mulligan K, Schambelan M, Grunfeld C. The metabolic effects of lopinavir/ritonavir in HIV-negative men. AIDS. 2004 Mar 5;18(4):641-9. doi: 10.1097/00002030-200403050-00008.
- Results publication: PubMed 15097312Lee GA, Mafong DD, Noor MA, Lo JC, Mulligan K, Schwarz JM, Schambelan M, Grunfeld C. HIV protease inhibitors increase adiponectin levels in HIV-negative men. J Acquir Immune Defic Syndr. 2004 May 1;36(1):645-7. doi: 10.1097/00126334-200405010-00017. No abstract available.
- Results publication: PubMed 15316349Schwarz JM, Lee GA, Park S, Noor MA, Lee J, Wen M, Lo JC, Mulligan K, Schambelan M, Grunfeld C. Indinavir increases glucose production in healthy HIV-negative men. AIDS. 2004 Sep 3;18(13):1852-4. doi: 10.1097/00002030-200409030-00017.
- Results publication: PubMed 16091248Lee GA, Rao MN, Grunfeld C. The effects of HIV protease inhibitors on carbohydrate and lipid metabolism. Curr HIV/AIDS Rep. 2005 Feb;2(1):39-50. doi: 10.1007/s11904-996-0008-z.
- Results publication: PubMed 16886163Lee GA, Lo JC, Aweeka F, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Single-dose lopinavir-ritonavir acutely inhibits insulin-mediated glucose disposal in healthy volunteers. Clin Infect Dis. 2006 Sep 1;43(5):658-60. doi: 10.1086/505974. Epub 2006 Jul 26.
- Results publication: PubMed 18090045Lee GA, Rao M, Mulligan K, Lo JC, Aweeka F, Schwarz JM, Schambelan M, Grunfeld C. Effects of ritonavir and amprenavir on insulin sensitivity in healthy volunteers. AIDS. 2007 Oct 18;21(16):2183-90. doi: 10.1097/QAD.0b013e32826fbc54.
- Derived from this study: PubMed 20595906Taylor SA, Lee GA, Pao VY, Anthonypillai J, Aweeka FT, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. Boosting dose ritonavir does not alter peripheral insulin sensitivity in healthy HIV-seronegative volunteers. J Acquir Immune Defic Syndr. 2010 Nov;55(3):361-4. doi: 10.1097/QAI.0b013e3181e6a7d9.
- Derived from this study: PubMed 19890203Pao VY, Lee GA, Taylor S, Aweeka FT, Schwarz JM, Mulligan K, Schambelan M, Grunfeld C. The protease inhibitor combination lopinavir/ritonavir does not decrease insulin secretion in healthy, HIV-seronegative volunteers. AIDS. 2010 Jan 16;24(2):265-70. doi: 10.1097/QAD.0b013e328333af1c.
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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.
Carl Grunfeld, M.D., Ph.D. principal investigator
Northern California Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz in people with HIV Infections, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl Grunfeld, M.D., Ph.D. (415-750-2005, carl.grunfeld@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of HIV Protease Inhibitors on Glucose Metabolism by Hyperglycemic Clamp (time frame: 4 weeks). 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 NCT00525239, which also lists 10 linked publications.
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 Mar 2011.