HIV InfectionsPhase 4NCT00346697

Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

A Phase 4 study testing Omega-3 fatty acid administration in people with HIV Infections and AIDS, run by Brown, Todd, M.D., Ph.D. at 3 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

The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, AIDS, Dyslipidemia
What is being tested?: Omega-3 fatty acid administration
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 3 sitesUnited States
Study dates: Oct 2006to Apr 2010
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

Ability and willingness to give informed consent
Age ≥ 18 years
HIV-1 infection documented at any time prior to study entry
Fasting plasma triglyceride value between 200 and 1000 mg/dL on two occasions within 4 weeks
Subjects must be receiving a stable antiretroviral medication regimen for > 3 months without any anticipated changes during the study interval
Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception
On stable lipid modification pharmacotherapy for at least 8 weeks prior to study entry

Who cannot join

Hemoglobin A1C > 8.5 %
Uncontrolled hypothyroidism (TSH > 4.5)
HIV viral load > 5,000 copies/ml (cpm),
Active liver disease and/or liver transaminases greater than 2.0 X upper limit of normal
Active kidney disease or serum creatinine > 2.5 mg/dL
Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure

Show all 14Show fewer

Uncontrolled hypertension within 4 weeks of study entry (SBP > 180 mmHg or DBP > 100 mmHg)
Use of systemic cancer chemotherapy within 8 weeks of study entry
Pregnancy or breastfeeding
Drug or alcohol dependence, or other conditions which may affect study compliance
History of coagulopathy or use of anticoagulants such as warfarin
Use of omega-3 fatty acid preparation in the 12 weeks prior to randomization
Significant changes in clinical status from the Screening Visit which would preclude the patient from being an appropriate candidate.
Any of the following laboratory parameters: hematocrit < 25%, absolute neutrophil count < 1.5 x 10^9/L, platelets < 100 x 10^9/L or hemoglobin < 8.0 gm/dL

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johns Hopkins University
Baltimore, Maryland, 21287
Veterans Administration of Greater Los Angeles Health System
Los Angeles, California, 90073
Georgetown University
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of N-3 Fatty Acid on Plasma Triglyceride Levels in Hypertriglyceridemic HIV Patients Receiving Highly Active Antiretroviral Therapy

Read the detailed description

Hypertriglyceridemia is common among HIV-infected patients receiving Highly Active Antiretroviral Therapy (HAART). Although fibrates, statins, and niacin have all been used in the management of hypertriglyceridemia in HIV-infected patients, optimal control is difficult to achieve and other agents are needed. Omega-3 fatty acids are effective for lowering triglycerides in patients without HIV infection, but experience in HIV-infected patients is limited. In addition, omega-3 fatty acids may also have secondary benefits in decreasing bone resorption and decreasing markers of systemic inflammation. The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation. It is 8- week randomized, double-blind trial of omega-3 fatty acids (LOVAZA, GSK, Inc) compared to placebo in 48 HAART-treated HIV-infected patients with triglycerides between 250 and 1000 mg/dl receiving dietary counseling. Subjects will be recruited from three centers (Johns Hopkins, Georgetown, and Los Angeles VAMC). The primary endpoint will be the change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. Secondary endpoints include the effect of LOVAZA on other lipid targets (total cholesterol, LDL cholesterol, HDL-cholesterol), markers of systemic inflammation, markers of bone turnover, markers of insulin resistance, HIV-disease control (CD4+ counts, HIV viral loads), measures of hepatotoxicity (ALT), platelet function, and patient reports of adverse events. Omega-3 fatty acids may be a useful adjunct in the treatment of hypertriglyceridemia in HIV-infected patients, but additional controlled studies are needed to assess its safety and efficacy using a purified, standardized preparation.

Conditions: HIV Infections, AIDS, Dyslipidemia, Hypertriglyceridemia
Being tested: Omega-3 fatty acid administration, Placebo
Keywords: AIDS, HIV, HAART, Lipids, Triglycerides, Cholesterol, omega-3 fatty acids, bone turnover, inflammation, insulin resistance
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome, Dyslipidemias, Hypertriglyceridemia, Inflammation, Insulin Resistance

What participants receive

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

Omega-3 fatty acid administrationDrug
LOVAZA 1 gram capsules, 4 capsules daily
PlaceboDrug
Corn-oil placebo

Study groups in NCT00346697
Study group	Role	What they receive
LOVAZA	Experimental	4 g/d of omega-3 fatty acid esters, plus dietary counseling Receives: Drug: Omega-3 fatty acid administration
Placebo	Placebo comparator	Corn oil placebo, plus dietary counselling Receives: Drug: Placebo

What is being measured

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

Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks

Secondary outcomes (14)

Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Measured: 8 weeks
Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Measured: 8 weeks
Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Measured: 8 weeks
Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group
Measured: 8 weeks
Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group
Measured: 8 weeks
Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks
Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.
Measured: 8 weeks

Timeline

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

Oct 2006Apr 2010

First posted30 Jun 2006 (estimated)
Study startOct 2006
Primary completionApr 2010
Study completionApr 2010

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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00346697
Sponsor's protocol ID: K23AT002862-01
Other IDs: K23AT002862-01
Status last verified: Nov 2014
First submitted: 29 Jun 2006
Last updated: 5 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Metkus TS, Timpone J, Leaf D, Bidwell Goetz M, Harris WS, Brown TT. Omega-3 fatty acid therapy reduces triglycerides and interleukin-6 in hypertriglyeridemic HIV patients. HIV Med. 2013 Oct;14(9):530-9. doi: 10.1111/hiv.12046. Epub 2013 May 19.
PubMed 23683266

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 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of N-3 Fatty Acid on Plasma Triglyceride Levels in Hypertriglyceridemic HIV Patients Receiving Highly Active Antiretroviral Therapy
ClinicalTrials.gov ID: NCT00346697
Acronym / sponsor ID: K23AT002862-01
Conditions: HIV Infections, AIDS, Dyslipidemia, Hypertriglyceridemia
Keywords: AIDS, HIV, HAART, Lipids, Triglycerides, Cholesterol, omega-3 fatty acids, bone turnover
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Brown, Todd, M.D., Ph.D.
Collaborators: National Center for Complementary and Integrative Health (NCCIH), GlaxoSmithKline
Study start: Oct 2006
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 30 Jun 2006 (estimated)
Results: Posted 5 Nov 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LOVAZA	Experimental	Drug: Omega-3 fatty acid administration4 g/d of omega-3 fatty acid esters, plus dietary counseling
Placebo	Placebo comparator	Drug: PlaceboCorn oil placebo, plus dietary counselling

Who may qualify

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

Key inclusion criteria (7 listed)

Ability and willingness to give informed consent
Age ≥ 18 years
HIV-1 infection documented at any time prior to study entry
Fasting plasma triglyceride value between 200 and 1000 mg/dL on two occasions within 4 weeks
Subjects must be receiving a stable antiretroviral medication regimen for > 3 months without any anticipated changes during the study interval

Key exclusion criteria (14 listed)

Hemoglobin A1C > 8.5 %
Uncontrolled hypothyroidism (TSH > 4.5)
HIV viral load > 5,000 copies/ml (cpm),
Active liver disease and/or liver transaminases greater than 2.0 X upper limit of normal
Active kidney disease or serum creatinine > 2.5 mg/dL

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
Omega-3 fatty acid administrationLOVAZA 1 gram capsules, 4 capsules daily	Drug	LOVAZA
PlaceboCorn-oil placebo	Drug	Placebo

Primary outcome

Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks

14 secondary outcomes

Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time frame: 8 weeks
Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time frame: 8 weeks
Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time frame: 8 weeks
Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group
Time frame: 8 weeks
Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group
Time frame: 8 weeks
Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks
Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time frame: 8 weeks

Results and safety

Results posted to the registry on 5 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LOVAZA	24	24
Placebo	24	23

Primary outcome: Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: mg/dl

Measure	LOVAZA n = 24	Placebo n = 23
Value	-34 (-149 to 9.5)	40 (-51 to 123)

LOVAZA vs Placebo: p = 0.01, Wilcoxon (Mann-Whitney)

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LOVAZA	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Placebo	0 of 24 (0%)	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 5 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23683266Metkus TS, Timpone J, Leaf D, Bidwell Goetz M, Harris WS, Brown TT. Omega-3 fatty acid therapy reduces triglycerides and interleukin-6 in hypertriglyeridemic HIV patients. HIV Med. 2013 Oct;14(9):530-9. doi: 10.1111/hiv.12046. Epub 2013 May 19.

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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.

Todd T. Brown, MD principal investigator

Johns Hopkins University

David Leaf, MD principal investigator

Veterans Adminstration of Greater Los Angeles Health System

Mattew Goetz, MD principal investigator

Veterans Adminstration of Greater Los Angeles Health System

3 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 Omega-3 fatty acid administration in people with HIV Infections and AIDS, run by Brown, Todd, M.D., Ph.D. at 3 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 7 inclusion and 14 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. Some participants in this study may receive a placebo. 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 5 Nov 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 in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. (time frame: 8 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 NCT00346697, 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 5 Nov 2014.