HIVPhase 4NCT00757783

Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

A Phase 4 study testing ritonavir, darunavir and emtricitabine [FTC]/tenofovir [TDF] in people with HIV, run by Tibotec, Inc at 15 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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: HIV
What is being tested?: ritonavir, darunavir and emtricitabine [FTC]/tenofovir [TDF]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 15 sitesUnited States
Study dates: Oct 2008to Jul 2012
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV-1 RNA of 1000 copies/mL or more
No previous treatment with antiretroviral drugs for more than 10 days
Demonstrated sensitivity [Fold Change (FC) = lower Clinical Cut Off (CCO)] to tenofovir, darunavir and atazanavir
Demonstrated sensitivity to emtricitabine defined as absence of M184V/I mutation
Any CD4 (Cluster of Differentiation 4) cell count

Who cannot join

Body mass index >30 kg/m2
Laboratory parameters as follows: fasting glucose >110 mg/dL, Low-Density Lipoprotein (LDL) cholesterol >130 mg/dL, triglycerides >200 mg/dL
Presence of any currently active AIDS-defining illness
Treatment for primary HIV infection or postexposure prophylaxis for HIV
Patients with acute or chronic hepatitis A, B or C infection

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Fort Lauderdale, Florida
Study site
Glastonbury, Connecticut
Study site
Hillsborough, New Jersey
Study site
Indianapolis, Indiana
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
New York, New York
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
St Louis, Missouri
Study site
Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients

The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a fixed-dose background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg once daily). This study will also evaluate the safety (adverse events), effectiveness, and tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.

Read the detailed description

The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. This is a phase 4, multicenter, open-label, randomized (study drug assigned by chance), comparative study designed to compare changes in lipid, glucose, and insulin parameters in HIV-infected, anti-retroviral (ARV) naive patients treated with DRV/r 800/100 mg once daily (QD) versus atazanavir/ritonavir (ATV/r) 300/100 mg QD in combination with a common background of emtricitabine (FTC)/ tenofovir (TDF) 200/300 mg QD. In addition, changes in inflammatory markers will be measured. A substudy of the parent study TMC114HIV4023 will evaluate insulin sensitivity and endothelial function in a subset of patients. The study will be conducted at approximately 16 study sites in the United States. Approximately 60 HIV-1 infected, treatment-naive adult patients will be enrolled in the study. Screening will take place during a 4-week period. At the baseline visit, eligible patients will be randomized in a 1:1 ratio to receive DRV/r 800/100 mg QD or ATV/r 300/100 mg QD administered in combination with a fixed-dose background regimen consisting of emtricitabine (FTC)/tenofovir (TDF) 200/300 mg once daily. The treatment period is 48 weeks. Study assessments will be performed at clinic visits at the end of weeks 4, 8, 12, 24, 36, and 48. The primary endpoint will be assessed at week 12. All patients will return for follow up visits 1 week and 4 weeks after the completion of study treatment. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to twenty patients (evenly randomized to receive DRV/r or ATV/r) who meet additional entry criteria will be enrolled in the substudy. The study hypothesis is the change in triglycerides and other lipids from baseline to week 12 will be similar in the DRV/r arm versus the ATV/r arm. The substudy hypothesis is that DRV/r will not adversely affect insulin sensitivity or endothelial function during 12 weeks of therapy, and the change from baseline in insulin sensitivity and endothelial function will be similar in the DRV/r arm versus the ATV/r arm. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Patients will be randomized in a 1:1 ratio to receive darunavir/ritonavir 800/100 mg once daily (QD) plus emtricitabine (FTC)/tenofovir (TDF) 200/300 mg QD or atazanavir/ritonavir 300/100 mg QD plus emtricitabine (FTC)/tenofovir (TDF) for 48 weeks.

Conditions: HIV
Being tested: ritonavir, darunavir, emtricitabine [FTC]/tenofovir [TDF], atazanavir
Keywords: HIV, AIDS, Immunodeficiency Virus, Human, PREZISTA, darunavir, TMC114, Protease Inhibitor, Truvada, Atazanavir, REYATAZ, HIV Infections, Treatment Naïve
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

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

ritonavirDrug
100 mg capsule or tablet once daily for 48 weeks
ritonavirDrug
100 mg capsule or tablet once daily for 48 weeks
darunavirDrug
800 mg tablet once daily for 48 weeks
emtricitabine [FTC]/tenofovir [TDF]Drug
200/300 mg tablet once daily for 48 weeks
emtricitabine [FTC]/tenofovir [TDF]Drug
200/300 mg once daily for 48 weeks
atazanavirDrug
300 mg capsule once daily for 48 weeks

Study groups in NCT00757783
Study group	Role	What they receive
darunavir	Experimental	darunavir 800 mg tablet once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg tablet once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks Receives: Drug: ritonavir; Drug: darunavir; Drug: emtricitabine [FTC]/tenofovir [TDF]
atazanavir	Experimental	atazanavir 300 mg capsule once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks Receives: Drug: ritonavir; Drug: emtricitabine [FTC]/tenofovir [TDF]; Drug: atazanavir

What is being measured

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

Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Observed values.
Measured: Baseline, Week 12

Secondary outcomes (15)

Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Observed Values
Measured: Baseline, Week 12 and 48
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Observed Values
Measured: Baseline, Week 12 and 48
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Observed Values
Measured: Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Observed Values
Measured: Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Observed Values
Measured: Baseline, Week 12 and 48
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.
Measured: Baseline, Week 12 and 48
Change From Baseline in Glucose at Week 12 and 48.
Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.
Measured: Baseline, Week 12 and 48
Change From Baseline in Insulin at Week 12 and 48.
Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.
Measured: Baseline, Week 12 and 48
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).
Measured: Baseline, Week 12 and 48
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.
Measured: Week 12 and 48
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.
Measured: Week 12 and 48
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.
Measured: Baseline, Week 12 and 48
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.
Measured: Baseline, Week 12 and 48
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.
Measured: Baseline, Week 12 and 48
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.
Measured: Baseline, Week 12 and 48

Timeline

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

Oct 2008Jul 2012

First posted23 Sep 2008 (estimated)
Study startOct 2008
Primary completionAug 2009
Study completionJul 2012

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 (2)Papers the sponsor has linked to this study.
Other trials for HIVStudies 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00757783
Sponsor's protocol ID: CR015439
Other IDs: TMC114HIV4023
Status last verified: Nov 2015
First submitted: 19 Sep 2008
Last updated: 30 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Overton ET, Tebas P, Coate B, Ryan R, Perniciaro A, Dayaram YK, De La Rosa G, Baugh BP. Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial. HIV Clin Trials. 2016 Mar;17(2):72-7. doi: 10.1080/15284336.2016.1141468.
PubMed 26917112
Gupta SK, Mi D, Liu Z, Saha C. Endothelial, inflammatory, coagulation, metabolic effects and safety of etravirine in HIV-uninfected volunteers. AIDS Patient Care STDS. 2011 Jun;25(6):327-31. doi: 10.1089/apc.2011.0011. Epub 2011 Apr 6.
PubMed 21470045

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 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients
ClinicalTrials.gov ID: NCT00757783
Acronym / sponsor ID: CR015439
Conditions: HIV
Keywords: HIV, AIDS, Immunodeficiency Virus, Human, PREZISTA, darunavir, TMC114, Protease Inhibitor, Truvada
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Tibotec, IncIndustry (pharma, biotech, devices)
Collaborators: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Study start: Oct 2008
Primary completion: Aug 2009 (actual)
Study completion: Jul 2012 (actual)
First posted: 23 Sep 2008 (estimated)
Results: Posted 10 Sep 2010

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: None (open label)
Number of arms: 2

Arm	Type	Receives
darunavir	Experimental	Drug: ritonavir, Drug: darunavir, Drug: emtricitabine [FTC]/tenofovir [TDF]darunavir 800 mg tablet once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg tablet once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks
atazanavir	Experimental	Drug: ritonavir, Drug: emtricitabine [FTC]/tenofovir [TDF], Drug: atazanaviratazanavir 300 mg capsule once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

HIV-1 RNA of 1000 copies/mL or more
No previous treatment with antiretroviral drugs for more than 10 days
Demonstrated sensitivity [Fold Change (FC) = lower Clinical Cut Off (CCO)] to tenofovir, darunavir and atazanavir
Demonstrated sensitivity to emtricitabine defined as absence of M184V/I mutation
Any CD4 (Cluster of Differentiation 4) cell count

Key exclusion criteria (5 listed)

Body mass index >30 kg/m2
Laboratory parameters as follows: fasting glucose >110 mg/dL, Low-Density Lipoprotein (LDL) cholesterol >130 mg/dL, triglycerides >200 mg/dL
Presence of any currently active AIDS-defining illness
Treatment for primary HIV infection or postexposure prophylaxis for HIV
Patients with acute or chronic hepatitis A, B or C infection

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
ritonavir100 mg capsule or tablet once daily for 48 weeks	Drug	darunavir
ritonavir100 mg capsule or tablet once daily for 48 weeks	Drug	atazanavir
darunavir800 mg tablet once daily for 48 weeks	Drug	darunavir
emtricitabine [FTC]/tenofovir [TDF]200/300 mg tablet once daily for 48 weeks	Drug	darunavir
emtricitabine [FTC]/tenofovir [TDF]200/300 mg once daily for 48 weeks	Drug	atazanavir
atazanavir300 mg capsule once daily for 48 weeks	Drug	atazanavir

Primary outcome

Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Time frame: Baseline, Week 12
Observed values.

15 secondary outcomes

Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Time frame: Baseline, Week 12 and 48
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Glucose at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Insulin at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Time frame: Week 12 and 48
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Time frame: Week 12 and 48
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
Time frame: Baseline, Week 12 and 48
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Time frame: Baseline, Week 12 and 48
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Time frame: Baseline, Week 12 and 48
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Time frame: Baseline, Week 12 and 48

Results and safety

Results posted to the registry on 10 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Darunavir	34	29
Atazanavir	31	25

Primary outcome: Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: milligram per deciliters (mg/dL)

Measure	Darunavir n = 28	Atazanavir n = 27
Baseline (n=28,27)	113.7 (57.40)	114.2 (84.05)
Change at Week 12 (n=27,27)	22.0 (62.72)	8.1 (81.15)

Population analysed: The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Darunavir	5 of 31 (16.1%)	28 of 31 (90.3%)	Not reported
Atazanavir	5 of 29 (17.2%)	25 of 29 (86.2%)	Not reported

Limitations and caveats (from the sponsor): 65 subjects were enrolled/treated in the main study. 3 subjects were enrolled, randomized, not treated and excluded from analyses (n=68). An additional 18 subjects were enrolled in a substudy extension and excluded from the main analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26917112Overton ET, Tebas P, Coate B, Ryan R, Perniciaro A, Dayaram YK, De La Rosa G, Baugh BP. Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial. HIV Clin Trials. 2016 Mar;17(2):72-7. doi: 10.1080/15284336.2016.1141468.
Derived from this study: PubMed 21470045Gupta SK, Mi D, Liu Z, Saha C. Endothelial, inflammatory, coagulation, metabolic effects and safety of etravirine in HIV-uninfected volunteers. AIDS Patient Care STDS. 2011 Jun;25(6):327-31. doi: 10.1089/apc.2011.0011. Epub 2011 Apr 6.

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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.

Tibotec, Inc. Clinical Trial study director

Tibotec, Inc

15 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 ritonavir, darunavir and emtricitabine [FTC]/tenofovir [TDF] in people with HIV, run by Tibotec, Inc at 15 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 5 inclusion and 5 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 10 Sep 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?

Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12 (time frame: Baseline, Week 12). 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 NCT00757783, which also lists 2 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 30 Dec 2015.