HIV InfectionsPhase 4NCT00055120
When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
A Phase 4 study testing Emtricitabine/tenofovir disoproxil fumarate, Lopinavir/ritonavir and Stavudine in people with HIV Infections and AIDS-Related Opportunistic Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, AIDS-Related Opportunistic Infections
- What is being tested?
- Emtricitabine/tenofovir disoproxil fumarate, Lopinavir/ritonavir and Stavudine
- How many people
- 283 participants
- Where
- 45 sitesin 3 countries
- Study dates
- Mar 2003to Aug 2007
- Phase
- Phase 4
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 infected
- Currently being treated for OI (including Pneumocystis carinii pneumonia [PCP]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex [MAC]; cytomegalovirus [CMV] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry.
- Able to take oral medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable methods of contraception
Who cannot join
- Any ART within 8 weeks prior to study entry
- 31 or more days of any ARV within 6 months prior to entry
- History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons
- Systemic cancer chemotherapy within 30 days prior to study entry
- Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma)
- Investigational ARV agents at study entry
Show all 14Show fewer
- Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion
- Anticipated use of certain medications
- Kidney failure requiring dialysis
- Current drug or alcohol use that, in the opinion of the study official, would interfere with the study
- Treatment for current, first-treated, and diagnosed OI or BI for more than 14 days prior to study entry
- Known resistance to ART that prohibits administration of an effective ART regimen
- Current OI has recurred within 90 days prior to study entry. Recurrent BIs are not excluded.
- Pregnant or breastfeeding
Trial locations and contacts
45 sites in 3 countries.
45 sites in 3 countries
United States43 sites
Emory University
Atlanta, Georgia, 30308
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287-8106
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, 02114
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Brigham and Womens Hospital
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27514
Northwestern University
Chicago, Illinois, 60611-3015
Cook County Hospital Core Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267-0405
Case Western Reserve University
Cleveland, Ohio, 44106-5083
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
Ohio State University
Columbus, Ohio, 43210
University of Texas, Southwestern Medical Center
Dallas, Texas, 75235-9173
University of Colorado Health Sciences Center, Denver
Denver, Colorado, 80262-3706
Duke University Medical Center
Durham, North Carolina, 27710
Univ of Texas, Galveston
Galveston, Texas, 77555-0435
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-1261
Indiana University Hosp
Indianapolis, Indiana, 46202-5250
Wishard Hospital
Indianapolis, Indiana, 46202
Univ of Miami
Miami, Florida, 33136-1013
Hennepin County Medical Clinic
Minneapolis, Minnesota, 55455-0392
Comprehensive Care Clinic
Nashville, Tennessee, 37203
Beth Israel Medical Center
New York, New York, 10003
NYU/Bellevue
New York, New York, 10016-6481
Columbia University
New York, New York, 10021
Presbyterian Medical Center - University of PA
Philadelphia, Pennsylvania, 19104
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02906
The Miriam Hospital
Providence, Rhode Island, 02906
Community Health Network, Inc.
Rochester, New York, 14642-0001
University of Rochester Medical Center
Rochester, New York, 14642-0001
University of California, Davis Medical Center
Sacramento, California, 95814
University of California, San Diego Antiviral Rese
San Diego, California, 92103
San Francisco General Hospital
San Francisco, California, 94110
University of Washington (Seattle)
Seattle, Washington, 98104
St. Louis Connect Care
St Louis, Missouri, 63108-2138
Washington University (St. Louis)
St Louis, Missouri, 63108-2138
San Mateo County AIDS Program
Stanford, California, 94305-5107
Santa Clara Valley Medical Center
Stanford, California, 94305-5107
Stanford Univ
Stanford, California, 94305-5107
Willow Clinic
Stanford, California, 94305-5107
Harbor General/UCLA
Torrance, California, 90502-2052
About this study
Official title: A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
Read the detailed description
Despite the advent of highly active antiretroviral therapy (HAART), many HIV infected patients without access to antiretroviral therapy (ART) present with acute OIs. Such presentations pose a management problem, as there are currently no data available as to whether initiating HAART during the acute presentation is of benefit. Reports of an immune reconstitution inflammatory syndrome (IRIS) marked by increasing hypoxia or new pulmonary infiltrates have been associated with the initiation of ART in patients with AIDS. There is also concern as to drug interactions between ART and antimicrobials used to treat the presenting OI. This study will evaluate the possible benefits and costs of initiating ART in HIV infected patients who present with an AIDS-defining OI.
There are 2 steps in this study. In Step 1, patients will be randomly assigned to one of two study arms. Arm A will receive ART within 2 weeks of starting therapy for the acute OI. Arm B will have ART deferred until Step 2, at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI. Only Arm B participants will enter Step 2, which will likely begin between Weeks 6 and 12. The study will make the following drugs available for construction of an antiretroviral (ARV) regimen: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/RTV), and stavudine (d4T). Use of other ARV drugs is at the discretion of the study official. Drug regimen additions and substitutions will be made on a case-by-case basis.
Patients will be followed for 48 weeks and will have 10 study visits. All study visits will include a physical exam, medication history, and blood collection. Patients will be asked to complete questionnaires assessing health status and adherence at selected visits.
- Being tested
- Emtricitabine/tenofovir disoproxil fumarate, Lopinavir/ritonavir, Stavudine
- Keywords
- Anti-HIV Agents, Disease Progression, Drug Administration Schedule, Viral Load, HIV-1, Treatment Outcome, Survival Analysis, Treatment Naive
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine/tenofovir disoproxil fumarateDrug
Lopinavir/ritonavirDrug
StavudineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
Secondary outcomes (9)
HIV-1 plasma viral load at all timepoints up to and including Week 48
CD4 counts at all timepoints up to and including Week 48
changes in ARV regimen for lack of efficacy
efficacy of treatment and clinical outcomes for specific OI/BI, including duration of and complications of treatment, incidence and duration of hospitalization, rate of relapse/recurrence, and incidence of IRIS and impact on outcomes in the two arms
safety and tolerability, measured by Grade 3 and 4 signs and symptoms and laboratory toxicities, ART and OI/BI treatment changes and dose modifications due to toxicities, and IRIS
HIV-1 drug resistance over time (genotype)
health care resource use, including total inpatient days and emergency room visits compared in the two groups
quality of life (QOL) and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at Week 48
adherence, including self-reported adherence to all ARVs over the study period, examined for relationship with primary study outcomes, including death, progression, and viral suppression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2003 (estimated)
- Study startMar 2003
- Primary completionSep 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Andrew R. Zolopa, MD, Study chair, Division of Infectious Diseases, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055120
- Sponsor's protocol ID
- ACTG A5164
- Other IDs
- DAIDS-ES ID 10005
- Status last verified
- Oct 2014
- First submitted
- 19 Feb 2003
- Last updated
- 15 Oct 2014
- Results posted
- No
Publications
Wislez M, Bergot E, Antoine M, Parrot A, Carette MF, Mayaud C, Cadranel J. Acute respiratory failure following HAART introduction in patients treated for Pneumocystis carinii pneumonia. Am J Respir Crit Care Med. 2001 Sep 1;164(5):847-51. doi: 10.1164/ajrccm.164.5.2007034.
PubMed 11549544Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77. doi: 10.1097/00002030-200107270-00006.
PubMed 11504958Hamill RJ. Immune restoration syndrome in AIDS and mycoses. Program and abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy; December 16-19, 2001; Chicago, IL. Abtract 1272.
Nunez M, Asencio R, Valencia ME, Leal M, Gonzalez-Lahoz J, Soriano V. Rate, causes, and clinical implications of presenting with low CD4+ cell counts in the era of highly active antiretroviral therapy. AIDS Res Hum Retroviruses. 2003 May;19(5):363-8. doi: 10.1089/088922203765551719.
PubMed 12803995Sax PE, Sloan CE, Schackman BR, Grant PM, Rong J, Zolopa AR, Powderly W, Losina E, Freedberg KA; Cepac US And Actg A5164 Investigators. Early antiretroviral therapy for patients with acute aids-related opportunistic infections: a cost-effectiveness analysis of ACTG A5164. HIV Clin Trials. 2010 Sep-Oct;11(5):248-59. doi: 10.1310/hct1105-248.
PubMed 21126955Grant PM, Komarow L, Andersen J, Sereti I, Pahwa S, Lederman MM, Eron J, Sanne I, Powderly W, Hogg E, Suckow C, Zolopa A. Risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred ART during an opportunistic infection. PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.
PubMed 20617176Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.
PubMed 19440326
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00055120
- Acronym / sponsor ID
- ACTG A5164
- Keywords
- Anti-HIV Agents, Disease Progression, Drug Administration Schedule, Viral Load, HIV-1, Treatment Outcome, Survival Analysis, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Feb 2003 (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.
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
Detailed description
Despite the advent of highly active antiretroviral therapy (HAART), many HIV infected patients without access to antiretroviral therapy (ART) present with acute OIs. Such presentations pose a management problem, as there are currently no data available as to whether initiating HAART during the acute presentation is of benefit. Reports of an immune reconstitution inflammatory syndrome (IRIS) marked by increasing hypoxia or new pulmonary infiltrates have been associated with the initiation of ART in patients with AIDS. There is also concern as to drug interactions between ART and antimicrobials used to treat the presenting OI. This study will evaluate the possible benefits and costs of initiating ART in HIV infected patients who present with an AIDS-defining OI.
There are 2 steps in this study. In Step 1, patients will be randomly assigned to one of two study arms. Arm A will receive ART within 2 weeks of starting therapy for the acute OI. Arm B will have ART deferred until Step 2, at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI. Only Arm B participants will enter Step 2, which will likely begin between Weeks 6 and 12. The study will make the following drugs available for construction of an antiretroviral (ARV) regimen: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/RTV), and stavudine (d4T). Use of other ARV drugs is at the discretion of the study official. Drug regimen additions and substitutions will be made on a case-by-case basis.
Patients will be followed for 48 weeks and will have 10 study visits. All study visits will include a physical exam, medication history, and blood collection. Patients will be asked to complete questionnaires assessing health status and adherence at selected visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infected
- Currently being treated for OI (including Pneumocystis carinii pneumonia [PCP]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex [MAC]; cytomegalovirus [CMV] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry.
- Able to take oral medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable methods of contraception
Key exclusion criteria (14 listed)
- Any ART within 8 weeks prior to study entry
- 31 or more days of any ARV within 6 months prior to entry
- History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons
- Systemic cancer chemotherapy within 30 days prior to study entry
- Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma)
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 |
|---|---|---|
| Emtricitabine/tenofovir disoproxil fumarate | Drug | – |
| Lopinavir/ritonavir | Drug | – |
| Stavudine | Drug | – |
Primary outcome
Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
9 secondary outcomes
HIV-1 plasma viral load at all timepoints up to and including Week 48
CD4 counts at all timepoints up to and including Week 48
changes in ARV regimen for lack of efficacy
efficacy of treatment and clinical outcomes for specific OI/BI, including duration of and complications of treatment, incidence and duration of hospitalization, rate of relapse/recurrence, and incidence of IRIS and impact on outcomes in the two arms
safety and tolerability, measured by Grade 3 and 4 signs and symptoms and laboratory toxicities, ART and OI/BI treatment changes and dose modifications due to toxicities, and IRIS
HIV-1 drug resistance over time (genotype)
health care resource use, including total inpatient days and emergency room visits compared in the two groups
quality of life (QOL) and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at Week 48
adherence, including self-reported adherence to all ARVs over the study period, examined for relationship with primary study outcomes, including death, progression, and viral suppression
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 2014.
- Background: PubMed 11549544Wislez M, Bergot E, Antoine M, Parrot A, Carette MF, Mayaud C, Cadranel J. Acute respiratory failure following HAART introduction in patients treated for Pneumocystis carinii pneumonia. Am J Respir Crit Care Med. 2001 Sep 1;164(5):847-51. doi: 10.1164/ajrccm.164.5.2007034.
- Background: PubMed 11504958Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77. doi: 10.1097/00002030-200107270-00006.
- BackgroundHamill RJ. Immune restoration syndrome in AIDS and mycoses. Program and abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy; December 16-19, 2001; Chicago, IL. Abtract 1272.
- Background: PubMed 12803995Nunez M, Asencio R, Valencia ME, Leal M, Gonzalez-Lahoz J, Soriano V. Rate, causes, and clinical implications of presenting with low CD4+ cell counts in the era of highly active antiretroviral therapy. AIDS Res Hum Retroviruses. 2003 May;19(5):363-8. doi: 10.1089/088922203765551719.
- Results publication: PubMed 21126955Sax PE, Sloan CE, Schackman BR, Grant PM, Rong J, Zolopa AR, Powderly W, Losina E, Freedberg KA; Cepac US And Actg A5164 Investigators. Early antiretroviral therapy for patients with acute aids-related opportunistic infections: a cost-effectiveness analysis of ACTG A5164. HIV Clin Trials. 2010 Sep-Oct;11(5):248-59. doi: 10.1310/hct1105-248.
- Derived from this study: PubMed 20617176Grant PM, Komarow L, Andersen J, Sereti I, Pahwa S, Lederman MM, Eron J, Sanne I, Powderly W, Hogg E, Suckow C, Zolopa A. Risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred ART during an opportunistic infection. PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.
- Derived from this study: PubMed 19440326Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.
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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.
Andrew R. Zolopa, MD study chair
Division of Infectious Diseases, Stanford University
45 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emtricitabine/tenofovir disoproxil fumarate, Lopinavir/ritonavir and Stavudine in people with HIV Infections and AIDS-Related Opportunistic Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 3 countries.
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 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Puerto Rico, South Africa. 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?
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?
Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48. 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 NCT00055120, which also lists 7 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 15 Oct 2014.