Infection, Human Immunodeficiency VirusPhase 1NCT01622790

Evaluation of the Bioequivalence of a Combined Formulated Tablet

A Phase 1 study testing Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg and abacavir 600 mg/lamivudine 300 mg in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site 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 55 yearsHealthy volunteers can take part
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg and abacavir 600 mg/lamivudine 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Aug 2012
Phase: Phase 1
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation.
Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral salpingo-oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 mIUml and estradiol less than 40 pg/ml (less than 146.8 pmol/L) is confirmatory]. Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study drug.
Body weight greater than and equal to 50 kg for males and greater than and equal to 45 kg for females and BMI within the range 18.5- 31.0 kg/m2 (inclusive).
ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
A negative HLA-B*5701 allele screening assessment
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Who cannot join

The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of greater than 14 drinks/week for men or greater than 7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.

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Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
A positive test for HIV antibody.
History of Gilbert's disease.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects. A single repeat is allowed for eligibility determination.
Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate: Males less than 45 and greater than 110 bpm; Females less than 50 and greater than100 bpm; PR Interval: Males less than 120 and greater than 220 msec; QRS duration: Males less than 70 and greater than 120 msec; QTc interval (Bazett): Males greater than 450 msec; Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization); Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome), non-sustained or sustained ventricular tachycardia (greater than and equal to 3 consecutive ventricular ectopic beats), and sinus pauses greater than 3 seconds; Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg Dolutegravir/Abacavir/Lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg Abacavir/Lamivudine) Tablet Administered Concurrently and the Effect of Food on Bioavailability of the Combined Formulation in Healthy Adult Subjects

Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line regimen due in large part to its convenient presentation as a full treatment regimen in a single product, other options are needed. A fixed-dose combination of DTG/abacavir (ABC)/lamivudine (3TC) is one such opportunity. Part A of this study will be a single-dose, two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG tablet that is currently being used in the Phase 3 clinical trials and the already marketed FDC tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy subjects that have already participated in Part A of the study. There will be a screening visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14 days after the last dose. There will be a 7 day washout between doses in each treatment period. The following PK parameters for DTG, ABC and 3TC will be measured: area under the concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax (tmax), terminal phase half-life (t½), terminal elimination phase rate constant (λz), percentage of AUC obtained by extrapolation (%AUCex),apparent clearance following oral dosing (CL/F) and apparent terminal phase volume

Conditions: Infection, Human Immunodeficiency Virus
Being tested: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg, abacavir 600 mg/lamivudine 300 mg
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgDrug
Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)
Dolutegravir 50 mgDrug
Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.
abacavir 600 mg/lamivudine 300 mgDrug
Also called KIVEXA. This is a trademark of ViiV Healthcare, EPZICOM. This is a trademark of ViiV Healthcare.
This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors

Study groups in NCT01622790
Study group	Role	What they receive
Arm 1	Experimental	33 subjects will receive a single dose of each of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 1followed by dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Receives: Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg; Drug: Dolutegravir 50 mg; Drug: abacavir 600 mg/lamivudine 300 mg
Arm 2	Experimental	33 subjects will receive dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 1 followed by a single dose of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Receives: Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg; Drug: Dolutegravir 50 mg; Drug: abacavir 600 mg/lamivudine 300 mg

What is being measured

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

Plasma DTG(dolutegravir), ABC (Abacavir) and 3TC(Lamivudine) PK(Pharmacokinetic) parameters, Area under the concentration-time curve from time zero (pre-dose)
Plasma PK samples will be collected pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post- dose.
Measured: For 48 hours after dosing on Day 1 of Periods 1, 2 and 3. Period 3 only applies to those subjects in Part B)

Secondary outcomes (2)

• Safety and tolerability parameters as assessed by change from baseline in 12-lead ECG and vital signs (BP and HR), number of subjects with adverse events and toxicity grading of clinical laboratory tests.
Measured: Up to 28 days
Plasma DTG, ABC and 3TC PK parameters tlag, tmax, t½, Terminal elimination phase rate constant, %AUCex, CL/F and Vz/F, and DTG C24
Plasma PK samples will be collected pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post- dose.
Measured: For 48 hours after dosing on Day 1 of Periods 1, 2 and 3. Period 3 only applies to those subjects in Part B)

Timeline

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

Jun 2012Aug 2012

First posted19 Jun 2012 (estimated)
Study startJun 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01622790
Sponsor's protocol ID: 114580
Status last verified: Oct 2012
First submitted: 31 May 2012
Last updated: 15 Oct 2012
Results posted: No
Data monitoring committee: No

Publications

Weller S, Chen S, Borland J, Savina P, Wynne B, Piscitelli SC. Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food. J Acquir Immune Defic Syndr. 2014 Aug 1;66(4):393-8. doi: 10.1097/QAI.0000000000000193.
PubMed 24798770

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 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg Dolutegravir/Abacavir/Lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg Abacavir/Lamivudine) Tablet Administered Concurrently and the Effect of Food on Bioavailability of the Combined Formulation in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01622790
Acronym / sponsor ID: 114580
Conditions: Infection, Human Immunodeficiency Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Shionogi, GlaxoSmithKline
Study start: Jun 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 19 Jun 2012 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Drug: Dolutegravir 50 mg, Drug: abacavir 600 mg/lamivudine 300 mg33 subjects will receive a single dose of each of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 1followed by dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose.
Arm 2	Experimental	Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Drug: Dolutegravir 50 mg, Drug: abacavir 600 mg/lamivudine 300 mg33 subjects will receive dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 1 followed by a single dose of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation.
Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral salpingo-oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 mIUml and estradiol less than 40 pg/ml (less than 146.8 pmol/L) is confirmatory]. Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study drug.
Body weight greater than and equal to 50 kg for males and greater than and equal to 45 kg for females and BMI within the range 18.5- 31.0 kg/m2 (inclusive).

Key exclusion criteria (16 listed)

The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of greater than 14 drinks/week for men or greater than 7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.

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
Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgDolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)	Drug	Arm 1, Arm 2
Dolutegravir 50 mgDolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.	Drug	Arm 1, Arm 2
abacavir 600 mg/lamivudine 300 mgAlso: KIVEXA. This is a trademark of ViiV Healthcare, EPZICOM. This is a trademark of ViiV Healthcare.This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors	Drug	Arm 1, Arm 2

Primary outcome

Plasma DTG(dolutegravir), ABC (Abacavir) and 3TC(Lamivudine) PK(Pharmacokinetic) parameters, Area under the concentration-time curve from time zero (pre-dose)
Time frame: For 48 hours after dosing on Day 1 of Periods 1, 2 and 3. Period 3 only applies to those subjects in Part B)
Plasma PK samples will be collected pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post- dose.

2 secondary outcomes

• Safety and tolerability parameters as assessed by change from baseline in 12-lead ECG and vital signs (BP and HR), number of subjects with adverse events and toxicity grading of clinical laboratory tests.
Time frame: Up to 28 days
Plasma DTG, ABC and 3TC PK parameters tlag, tmax, t½, Terminal elimination phase rate constant, %AUCex, CL/F and Vz/F, and DTG C24
Time frame: For 48 hours after dosing on Day 1 of Periods 1, 2 and 3. Period 3 only applies to those subjects in Part B)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Derived from this study: PubMed 24798770Weller S, Chen S, Borland J, Savina P, Wynne B, Piscitelli SC. Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food. J Acquir Immune Defic Syndr. 2014 Aug 1;66(4):393-8. doi: 10.1097/QAI.0000000000000193.

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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.

GSK Clinical Trials study director

ViiV Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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 15 Oct 2012. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Plasma DTG(dolutegravir), ABC (Abacavir) and 3TC(Lamivudine) PK(Pharmacokinetic) parameters, Area under the concentration-time curve from time zero (pre-dose) (time frame: For 48 hours after dosing on Day 1 of Periods 1, 2 and 3. Period 3 only applies to those subjects in Part B)). 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 NCT01622790, 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 15 Oct 2012.