HIV InfectionsPhase 4LARDNCT00756730

Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r

A Phase 4 study testing ATV/r and DRV/r in people with HIV Infections, run by Community Research Initiative of New England at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: ATV/r and DRV/r
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 11 sitesUnited States
Study dates: Sep 2008to Jun 2011
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and > or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to screening.
Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL<400 copies/ml) using an FDA approved assay for a minimum of twelve weeks prior to screening AND undetectable HIV viral load using an FDA approved ultrasensitive assay at screening.
No evidence of HIV protease resistance as defined by the Stanford HIV database
Currently receiving first protease inhibitor unless switch to LPV/r or FPV/r was for non-virologic reasons
Fasting triglycerides > 200 mg/dL
No ongoing issues that in the opinion of the investigator would lead to decreased ability to comply with the study procedures
If currently receiving a proton pump inhibitor, the dose is < omeprazole 20 mg or the equivalent dose of another proton pump inhibitor
If patient is receiving another lipid lowering medication, it must be at a stable dose

Who cannot join

Currently receiving an ART regimen other than > or equal to two NRTIs and either LPV/r or FPV/r
Prior use of darunavir or atazanavir
CDC Class C Illness diagnosed within 30 days of screening
Patient is currently receiving the following Hydroxamethylglutaryl-coA (HMGCoA) reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin
Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol, and colesevelam)
Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table with the following exceptions:

Show all 15Show fewer

Pre-existing diabetes mellitus with asymptomatic, nonfasting glucose grade 3 elevations
Subjects with asymptomatic grade 3 fasting triglyceride or cholesterol elevations
Clinical or laboratory evidence of clinically significant liver impairment/dysfunction disease or cirrhosis
Note: Individuals co-infected with chronic hepatitis B or C viruses will be allowed to enter the trial if their condition is clinically stable and they will not require therapy during the course of the study. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase
Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance
Use of any investigational agents 30 days prior to screening
Life expectancy < 6 months in the opinion of the investigator
Pregnancy or breast feeding
Female subject of childbearing potential (i.e., heterosexually active, and not surgically sterile or at least two years post-menopausal) not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Community Research Initiative
Boston, Massachusetts, 02215
David M. Lee, M.D., P.A., a/b/a Uptown Physicians Group
Dallas, Texas, 75204
Nicholaos C. Bellos, MD, PA
Dallas, Texas, 75204
AIDS Healthcare Foundation
Los Angeles, California, 02319
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Abbott Northwestern Infectious Disease and Travel Clinic
Minneapolis, Minnesota, 55404
Orlando Immunology Center
Orlando, Florida, 32803
Philadelphia Fight
Philadelphia, Pennsylvania, 19107
Spectrum Medical Group
Phoenix, Arizona, 85012
AIDS Community Health Center
Rochester, New York, 14804
Community Research Initiative - West
Springfield, Massachusetts, 01107

Other trials in United States

About this study

Official title: Randomized, Open-label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patients Experiencing Triglyceride Elevations While Receiving LPV/r or FPV/r.

For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.

Read the detailed description

This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.

Conditions: HIV Infections
Being tested: ATV/r, DRV/r
Keywords: lopinavir, ritonavir, atazanavir, fosamprenavir, darunavir, anti-retroviral, AIDS, HIV, LARD, triglyceride, protease inhibitors, treatment Experienced
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ATV/rDrug
Also called Atazanavir/r
Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
DRV/rDrug
We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Study groups in NCT00756730
Study group	Role	What they receive
Switch to DRV/r (800mg/100mg) QD	Other	We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study. Receives: Drug: DRV/r
Switch to ATV/r (300mg/100mg QD)	Other	We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this are the subject switched to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study Receives: Drug: ATV/r

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
Measured: baseline, 24 weeks
At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
Measured: 24 weeks
The Change in Fasting Triglyceride Level From Baseline to Week 24
Measured: Baseline to week 24

Secondary outcomes (5)

Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Measured: Week 4, 12 & 24
Difference in CD4 From Baseline to Week 24
Measured: baseline to Week 24
Total Cholesterol in the Two Study Groups at 24 Weeks
Measured: Week 24
LDL Cholesterol at Week 24
Measured: week 24
HDL Cholesterol at Week 24
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jun 2011

First posted22 Sep 2008 (estimated)
Study startSep 2008
Primary completionJun 2011
Study completionJun 2011

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00756730
Sponsor's protocol ID: 08-09
Acronym: LARD
Status last verified: Jul 2017
First submitted: 18 Sep 2008
Last updated: 21 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Open-label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patients Experiencing Triglyceride Elevations While Receiving LPV/r or FPV/r.
ClinicalTrials.gov ID: NCT00756730
Acronym / sponsor ID: LARD / 08-09
Conditions: HIV Infections
Keywords: lopinavir, ritonavir, atazanavir, fosamprenavir, darunavir, anti-retroviral, AIDS, HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Community Research Initiative of New EnglandUniversity, hospital or other
Collaborators: Tibotec Pharmaceutical Limited
Study start: Sep 2008
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 22 Sep 2008 (estimated)
Results: Posted 13 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Switch to DRV/r (800mg/100mg) QD	Other	Drug: DRV/rWe designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
Switch to ATV/r (300mg/100mg QD)	Other	Drug: ATV/rWe designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this are the subject switched to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and > or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to screening.
Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL<400 copies/ml) using an FDA approved assay for a minimum of twelve weeks prior to screening AND undetectable HIV viral load using an FDA approved ultrasensitive assay at screening.
No evidence of HIV protease resistance as defined by the Stanford HIV database
Currently receiving first protease inhibitor unless switch to LPV/r or FPV/r was for non-virologic reasons
Fasting triglycerides > 200 mg/dL

Key exclusion criteria (15 listed)

Currently receiving an ART regimen other than > or equal to two NRTIs and either LPV/r or FPV/r
Prior use of darunavir or atazanavir
CDC Class C Illness diagnosed within 30 days of screening
Patient is currently receiving the following Hydroxamethylglutaryl-coA (HMGCoA) reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin
Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol, and colesevelam)

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
ATV/rAlso: Atazanavir/rSwitch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.	Drug	Switch to ATV/r (300mg/100mg QD)
DRV/rWe designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.	Drug	Switch to DRV/r (800mg/100mg) QD

Primary outcome

Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
Time frame: baseline, 24 weeks
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
Time frame: 24 weeks
The Change in Fasting Triglyceride Level From Baseline to Week 24
Time frame: Baseline to week 24

5 secondary outcomes

Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Time frame: Week 4, 12 & 24
Difference in CD4 From Baseline to Week 24
Time frame: baseline to Week 24
Total Cholesterol in the Two Study Groups at 24 Weeks
Time frame: Week 24
LDL Cholesterol at Week 24
Time frame: week 24
HDL Cholesterol at Week 24
Time frame: 24 weeks

Results and safety

Results posted to the registry on 13 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD	25	25
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD	24	22

Primary outcome: Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.

Time frame: baseline, 24 weeks. Number. Unit: percentage of patients

Measure	Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD n = 25	Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD n = 22
Value	80	73

Population analysed: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.

Primary outcome: At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL

Time frame: 24 weeks. Number. Unit: percentage of participants

Measure	Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD n = 25	Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD n = 22
Value	48	55

Population analysed: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Primary outcome: The Change in Fasting Triglyceride Level From Baseline to Week 24

Time frame: Baseline to week 24. Mean (Full Range). Unit: mg/dL

Measure	Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD n = 25	Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD n = 22
Value	-126 (-312 to 133)	-88 (-469 to 90)

Population analysed: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD	1 of 25 (4%)	7 of 25 (28%)	Not reported
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD	1 of 24 (4.2%)	8 of 24 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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.

Daniel J Skiest, MD principal investigator

Community Research Initiative

11 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 ATV/r and DRV/r in people with HIV Infections, run by Community Research Initiative of New England at 11 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 8 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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 13 Jul 2012). 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?

Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24. (time frame: baseline, 24 weeks). The study lists 3 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 NCT00756730.

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 21 Aug 2017.