Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With HIV and HCV

NCT03324633 | Completed

• 1 other identifier: ANRS CO13 Hepavih cohort
• Study Type: observational
• Target: 1,850
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. The cohort, is unique in Europe with more than 1800 participants followed over 10 years including quality of life and compliance to treatment data.

Conditions

HIV; Hepatitis C

Keywords

HIV; HCV; cohort; natural history; cure

Outcome Measures

Primary Outcomes (1)

• Improve effectiveness and quality of medical care in Hepatitis C in HIV patients

  The CRFs compile clinical, biological, genetic and virological data : Clinical events, treatments (HIV, HVC, others), clinical exams (height, weight, hip and waist circumferences), virological : CD4, CD8, HIV RNA, HVC RNA (+genotype), HVB serology, liver functions tests and biology (fibroscan, fibrotest, ultrasound, transaminases, bilirubin, alkaline phosphatase, gamma GT,...), metabolic biochemistry (glycemia, insulin, cholesterol, creatinin, lipase). Patients also completed sociales sciences questionnaires (quality of life, depression,...) During the annual visit, samples are taken : blood for DNA, serum and plasma and are stocked in a biobank used for scientific projects.

  Through study completion : One visit/year for each participant + one additionnal visit every 6 months for patients with a cirhhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Co-infected patients with HIV and HVC who are usually treated in one of the clinical centres of the ANRS CO13 Hepavih network (28 located in metropolitan France since 2014)

You may qualify if:

• Patients aged ≥18 years,
• Cover by a social security,
• Able to understand the consent conform.
• Phase 1:
• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment)
• Phase 2:
• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with protease inhibitor based treatment (PegIFN, Ribavirin and Telaprevir or Boceprevir) or having cleared HCV spontaneously in the absence of anti-HCV treatment
• Phase 3:
• HIV-1/HCV chronically infected (positive HIV antibody test, and HCV RNA positive at inception or negative after anti-HCV treatment) treated with DAA anti-HCV treatment (all combinations)

You may not qualify if:

• Patients \<18 years old
• So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
• Without an healthcare insurance

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Bristol-Myers Squibb: collaborator
• GlaxoSmithKline: collaborator
• Merck Serono International SA: collaborator
• Roche Pharma AG: collaborator
• Schering-Plough: collaborator

Related Publications (37)

• Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaitre H, Boue F, Valantin MA, Dabis F, Salmon D, Wittkop L. All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus-coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13-HEPAVIH Cohort. Clin Infect Dis. 2016 Sep 15;63(6):763-770. doi: 10.1093/cid/ciw379. Epub 2016 Jun 17.

  PMID: 27317796 RESULT

• Marcellin F, Protopopescu C, Poizot-Martin I, Miailhes P, Esterle L, Wittkop L, Spire B, Bocquier A, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group. Short article: Fatigue in the long term after HCV treatment in HIV-HCV-coinfected patients: functional limitations persist despite viral clearance in patients exposed to peg-interferon/ribavirin-containing regimens (ANRS CO13-HEPAVIH cohort). Eur J Gastroenterol Hepatol. 2016 Sep;28(9):1003-7. doi: 10.1097/MEG.0000000000000664.

  PMID: 27177169 RESULT

• Marcellin F, Lions C, Rosenthal E, Roux P, Sogni P, Wittkop L, Protopopescu C, Spire B, Salmon-Ceron D, Dabis F, Carrieri MP; HEPAVIH ANRS CO13 Study Group*. No significant effect of cannabis use on the count and percentage of circulating CD4 T-cells in HIV-HCV co-infected patients (ANRS CO13-HEPAVIH French cohort). Drug Alcohol Rev. 2017 Mar;36(2):227-238. doi: 10.1111/dar.12398. Epub 2016 Apr 13.

  PMID: 27073179 RESULT

• Carrieri MP, Serfaty L, Vilotitch A, Winnock M, Poizot-Martin I, Loko MA, Lions C, Lascoux-Combe C, Roux P, Salmon-Ceron D, Spire B, Dabis F; ANRS CO13 HEPAVIH Study Group. Cannabis Use and Reduced Risk of Insulin Resistance in HIV-HCV Infected Patients: A Longitudinal Analysis (ANRS CO13 HEPAVIH). Clin Infect Dis. 2015 Jul 1;61(1):40-8. doi: 10.1093/cid/civ217. Epub 2015 Mar 16.

  PMID: 25778750 RESULT

• Marcellin F, Roux P, Loko MA, Lions C, Caumont-Prim A, Dabis F, Salmon-Ceron D, Spire B, Carrieri MP; HEPAVIH (ANRS CO13) Study Group. High levels of alcohol consumption increase the risk of advanced hepatic fibrosis in HIV/hepatitis C virus-coinfected patients: a sex-based analysis using transient elastography at enrollment in the HEPAVIH ANRS CO13 cohort. Clin Infect Dis. 2014 Oct 15;59(8):1190-2. doi: 10.1093/cid/ciu525. Epub 2014 Jul 11. No abstract available.

  PMID: 25015913 RESULT

• Salmon D, Bani-Sadr F, Gilbert C, Rosenthal E, Valantin MA, Simon A, Neau D, Morlat P, Loko MA, Wittkop L, Dabis F; ANRS CO13HEPAVIH study group. HCV viral load at baseline and at week 4 of telaprevir/boceprevir based triple therapies are associated with virological outcome in HIV/hepatitis C co-infected patients. J Clin Virol. 2015 Dec;73:32-35. doi: 10.1016/j.jcv.2015.10.010. Epub 2015 Oct 19.

  PMID: 26528903 RESULT

• ANRS CO13 HEPAVIH Cohort. Regression of liver stiffness after sustained hepatitis C virus (HCV) virological responses among HIV/HCV-coinfected patients. AIDS. 2015 Sep 10;29(14):1821-30. doi: 10.1097/QAD.0000000000000787.

  PMID: 26372388 RESULT

• Roux P, Lions C, Cohen J, Winnock M, Salmon-Ceron D, Bani-Sadr F, Sogni P, Spire B, Dabis F, Carrieri MP; ANRS-CO13-HEPAVIH Study Group. Impact of HCV treatment and depressive symptoms on adherence to HAART among HIV-HCV-coinfected patients: results from the ANRS-CO13-HEPAVIH cohort. Antivir Ther. 2014;19(2):171-8. doi: 10.3851/IMP2699. Epub 2013 Oct 28.

  PMID: 24166726 RESULT

• Marcellin F, Roux P, Winnock M, Lions C, Dabis F, Salmon-Ceron D, Loko MA, Spire B, Carrieri MP. Using patient-reported outcomes to improve the management of co-infection with HIV and HCV: the ANRS CO13 HEPAVIH cohort. Expert Rev Gastroenterol Hepatol. 2014 May;8(4):351-8. doi: 10.1586/17474124.2014.888949. Epub 2014 Mar 3.

  PMID: 24580042 RESULT

• Carrieri MP, Lions C, Sogni P, Winnock M, Roux P, Mora M, Bonnard P, Salmon D, Dabis F, Spire B; ANRS CO13 HEPAVIH Study Group. Association between elevated coffee consumption and daily chocolate intake with normal liver enzymes in HIV-HCV infected individuals: results from the ANRS CO13 HEPAVIH cohort study. J Hepatol. 2014 Jan;60(1):46-53. doi: 10.1016/j.jhep.2013.08.014. Epub 2013 Aug 24.

  PMID: 23978720 RESULT

• Bani-Sadr F, Loko MA, Pambrun E, Winnock M, Carrieri P, Gilbert C, Duvivier C, Bouchaud O, Gervais A, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Correlates of HIV sustained viral suppression in HIV/hepatitis C virus coinfected patients: possible role of the hepatitis C virus sustained viral response. AIDS. 2014 May 15;28(8):1155-60. doi: 10.1097/QAD.0000000000000218.

  PMID: 24499953 RESULT

• Winnock M, Bani-Sadr F, Pambrun E, Loko MA, Carrieri P, Neau D, Morlat P, Marchou B, Dabis F, Salmon D; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) CO13 HEPAVIH Study Group. Factors associated with guideline-based hepatitis C virus (HCV) treatment initiation in HIV/HCV-coinfected patients: role of comorbidities and physicians' perceptions. HIV Med. 2013 Aug;14(7):430-6. doi: 10.1111/hiv.12023. Epub 2013 Mar 5.

  PMID: 23461846 RESULT

• Marcellin F, Lions C, Winnock M, Salmon D, Durant J, Spire B, Mora M, Loko MA, Dabis F, Dominguez S, Roux P, Carrieri MP; ANRS CO13 HEPAVIH Study Group. Self-reported alcohol abuse in HIV-HCV co-infected patients: a better predictor of HIV virological rebound than physician's perceptions (HEPAVIH ARNS CO13 cohort). Addiction. 2013 Jul;108(7):1250-8. doi: 10.1111/add.12149. Epub 2013 Mar 21.

  PMID: 23421419 RESULT

• Trimoulet P, Merchadou L, Winnock M, Loko MA, Fleury H, Salmon D, Dabis F, Neau D; ANRS CO 13 HEPAVIH Study Group. Hepatitis C virus RNA quantitation in a nationwide French cohort of patients co-infected with HIV and HCV: should the same test be applied to all samples? J Virol Methods. 2012 Apr;181(1):131-3. doi: 10.1016/j.jviromet.2012.01.006. Epub 2012 Jan 20.

  PMID: 22285372 RESULT

• Solas C, Pambrun E, Winnock M, Salmon D, Poizot-Martin I, Dominguez S, Bani-Sadr F, Izopet J, Garraffo R, Peytavin G; ANRS CO-13 HEPAVIH Study Group. Ribavirin and abacavir drug interaction in HIV-HCV coinfected patients: fact or fiction? AIDS. 2012 Nov 13;26(17):2193-9. doi: 10.1097/QAD.0b013e32835763a4.

  PMID: 22781224 RESULT

• Salmon-Ceron D, Cohen J, Winnock M, Roux P, Sadr FB, Rosenthal E, Martin IP, Loko MA, Mora M, Sogni P, Spire B, Dabis F, Carrieri MP; HEPAVIH group. Engaging HIV-HCV co-infected patients in HCV treatment: the roles played by the prescribing physician and patients' beliefs (ANRS CO13 HEPAVIH cohort, France). BMC Health Serv Res. 2012 Mar 12;12:59. doi: 10.1186/1472-6963-12-59.

  PMID: 22409788 RESULT

• Salmon D, Bani-Sadr F, Loko MA, Stitou H, Gervais A, Durant J, Rosenthal E, Quertainmont Y, Barange K, Vittecoq D, Shoai-Tehrani M, Alvarez M, Winnock M, Trinchet JC, Dabis F, Sogni P. Insulin resistance is associated with a higher risk of hepatocellular carcinoma in cirrhotic HIV/HCV-co-infected patients: results from ANRS CO13 HEPAVIH. J Hepatol. 2012 Apr;56(4):862-8. doi: 10.1016/j.jhep.2011.11.009. Epub 2011 Dec 13.

  PMID: 22173166 RESULT

• Roux P, Fugon L, Winnock M, Salmon-Ceron D, Lacombe K, Sogni P, Spire B, Dabis F, Carrieri MP; ANRS-CO-13-HEPAVIH Study Group. Positive impact of hepatitis C virus (HCV) treatment on antiretroviral treatment adherence in human immunodeficiency virus-HCV coinfected patients: one more argument for expanded access to HCV treatment for injecting drug users. Addiction. 2012 Jan;107(1):152-9. doi: 10.1111/j.1360-0443.2011.03608.x. Epub 2011 Oct 12.

  PMID: 21819472 RESULT

• Loko MA, Bani-Sadr F, Valantin MA, Lascoux-Combe C, Fontaine H, Bonnard P, Gervais A, Bouchaud O, Garipuy D, Quertainmont Y, Vittecoq D, Tehrani MS, Winnock M, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Antiretroviral therapy and sustained virological response to HCV therapy are associated with slower liver fibrosis progression in HIV-HCV-coinfected patients: study from the ANRS CO 13 HEPAVIH cohort. Antivir Ther. 2012;17(7):1335-43. doi: 10.3851/IMP2419. Epub 2012 Oct 10.

  PMID: 23052829 RESULT

• Carrieri MP, Sogni P, Cohen J, Loko MA, Winnock M, Spire B; HEPAVIH Study Group. Elevated coffee consumption and reduced risk of insulin resistance in HIV-HCV coinfected patients (HEPAVIH ANRS CO-13). Hepatology. 2012 Nov;56(5):2010. doi: 10.1002/hep.25813. No abstract available.

  PMID: 22535683 RESULT

• Carrieri MP, Cohen J, Salmon-Ceron D, Winnock M. Coffee consumption and reduced self-reported side effects in HIV-HCV co-infected patients during PEG-IFN and ribavirin treatment: results from ANRS CO13 HEPAVIH. J Hepatol. 2012 Mar;56(3):745-7. doi: 10.1016/j.jhep.2011.08.005. Epub 2011 Aug 31. No abstract available.

  PMID: 21888878 RESULT

• Abravanel F, Raymond S, Pambrun E, Winnock M, Bonnard P, Sogni P, Trimoulet P, Dabis F, Salmon-Ceron D, Izopet J; ANRS CO13 HEPAVIH Study Group. HIV-1 tropism and liver fibrosis in HIV-HCV co-infected patients. PLoS One. 2012;7(11):e50289. doi: 10.1371/journal.pone.0050289. Epub 2012 Nov 30.

  PMID: 23226258 RESULT

• Winnock M, Bani-Sadr F, Pambrun E, Loko MA, Lascoux-Combe C, Garipuy D, Rosenthal E, Carrieri P, Dabis F, Salmon D. Prevalence of immunity to hepatitis viruses A and B in a large cohort of HIV/HCV-coinfected patients, and factors associated with HAV and HBV vaccination. Vaccine. 2011 Nov 3;29(47):8656-60. doi: 10.1016/j.vaccine.2011.08.125. Epub 2011 Sep 13.

  PMID: 21920402 RESULT

• Roux P, Cohen J, Lascoux-Combe C, Sogni P, Winnock M, Salmon-Ceron D, Spire B, Dabis F, Carrieri MP; ANRS-CO13-HEPAVIH study group. Determinants of the underreporting of alcohol consumption by HIV/HCV co-infected patients during face-to-face medical interviews: the role of the physician. Drug Alcohol Depend. 2011 Jul 1;116(1-3):228-32. doi: 10.1016/j.drugalcdep.2010.09.025. Epub 2011 Jan 15.

  PMID: 21239121 RESULT

• Loko MA, Bani-Sadr F, Winnock M, Lacombe K, Carrieri P, Neau D, Morlat P, Serfaty L, Dabis F, Salmon D; ANRS CO 13 HEPAVIH Study Group. Impact of HAART exposure and associated lipodystrophy on advanced liver fibrosis in HIV/HCV-coinfected patients. J Viral Hepat. 2011 Jul;18(7):e307-14. doi: 10.1111/j.1365-2893.2010.01417.x. Epub 2011 Jan 11.

  PMID: 21692942 RESULT

• Loko MA, Salmon D, Carrieri P, Winnock M, Mora M, Merchadou L, Gillet S, Pambrun E, Delaune J, Valantin MA, Poizot-Martin I, Neau D, Bonnard P, Rosenthal E, Barange K, Morlat P, Lacombe K, Gervais A, Rouges F, See AB, Lascoux-Combe C, Vittecoq D, Goujard C, Duvivier C, Spire B, Izopet J, Sogni P, Serfaty L, Benhamou Y, Bani-Sadr F, Dabis F; ANRS CO 13 HEPAVIH Study Group. The French national prospective cohort of patients co-infected with HIV and HCV (ANRS CO13 HEPAVIH): early findings, 2006-2010. BMC Infect Dis. 2010 Oct 22;10:303. doi: 10.1186/1471-2334-10-303.

  PMID: 20969743 RESULT

• Carrieri MP, Cohen J, Winnock M, Salmon D. Chocolate intake, depression, and clinical progression in HIV-HCV coinfected patients: still more questions than answers. Arch Intern Med. 2010 Sep 27;170(17):1607; author reply 1608-9. doi: 10.1001/archinternmed.2010.330. No abstract available.

  PMID: 20876416 RESULT

• Cales P, Halfon P, Batisse D, Carrat F, Perre P, Penaranda G, Guyader D, d'Alteroche L, Fouchard-Hubert I, Michelet C, Veillon P, Lambert J, Weiss L, Salmon D, Cacoub P. Comparison of liver fibrosis blood tests developed for HCV with new specific tests in HIV/HCV co-infection. J Hepatol. 2010 Aug;53(2):238-44. doi: 10.1016/j.jhep.2010.03.007. Epub 2010 Apr 18.

  PMID: 20493576 RESULT

• Carrieri MP, Protopopescu C, Marcellin F, Rosellini S, Wittkop L, Esterle L, Zucman D, Raffi F, Rosenthal E, Poizot-Martin I, Salmon-Ceron D, Dabis F, Spire B; ANRS CO13 HEPAVIH Study Group. Protective effect of coffee consumption on all-cause mortality of French HIV-HCV co-infected patients. J Hepatol. 2017 Dec;67(6):1157-1167. doi: 10.1016/j.jhep.2017.08.005. Epub 2017 Sep 21.

  PMID: 28942916 RESULT

• Yaya I, Roux P, Marcellin F, Salmon-Ceron D, Carrieri MP. Unstable Housing Still a Barrier to Receiving HCV Treatment in France (ANRS CO13 HEPAVIH Cohort). Dig Dis Sci. 2017 Oct;62(10):2943-2944. doi: 10.1007/s10620-017-4703-y. Epub 2017 Aug 5. No abstract available.

  PMID: 28780609 RESULT

• Knight R, Roux P, Vilotitch A, Marcellin F, Rosenthal E, Esterle L, Boue F, Rey D, Piroth L, Dominguez S, Sogni P, Salmon-Ceron D, Spire B, Carrieri MP; ANRS CO13-HEPAVIH Study Group. Significant reductions in alcohol use after hepatitis C treatment: results from the ANRS CO13-HEPAVIH cohort. Addiction. 2017 Sep;112(9):1669-1679. doi: 10.1111/add.13851. Epub 2017 Jun 6.

  PMID: 28430385 RESULT

• Marcellin F, Protopopescu C, Esterle L, Wittkop L, Piroth L, Aumaitre H, Bouchaud O, Goujard C, Vittecoq D, Dabis F, Salmon-Ceron D, Spire B, Roux P, Carrieri MP; ANRS CO13-HEPAVIH Study Group. Short article: Anger and quality of life in patients co-infected with HIV and hepatitis C virus: a cross-sectional study (ANRS CO13-HEPAVIH). Eur J Gastroenterol Hepatol. 2017 Jul;29(7):786-791. doi: 10.1097/MEG.0000000000000883.

  PMID: 28418984 RESULT

• Piroth L, Wittkop L, Lacombe K, Rosenthal E, Gilbert C, Miailhes P, Carrieri P, Chas J, Poizot-Martin I, Gervais A, Dominguez S, Neau D, Zucman D, Billaud E, Morlat P, Aumaitre H, Lascoux-Combe C, Simon A, Bouchaud O, Teicher E, Bani-Sadr F, Alric L, Vittecoq D, Boue F, Duvivier C, Valantin MA, Esterle L, Dabis F, Sogni P, Salmon D; ANRS CO13 HEPAVIH study group. Efficacy and safety of direct-acting antiviral regimens in HIV/HCV-co-infected patients - French ANRS CO13 HEPAVIH cohort. J Hepatol. 2017 Jul;67(1):23-31. doi: 10.1016/j.jhep.2017.02.012. Epub 2017 Feb 22.

  PMID: 28235612 RESULT

• Ulveling D, Le Clerc S, Cobat A, Labib T, Noirel J, Laville V, Coulonges C, Carpentier W, Nalpas B, Heim MH, Poynard T, Cerny A, Pol S, Bochud PY, Dabis F, Theodorou I, Levy Y, Salmon D, Abel L, Dominguez S, Zagury JF; HEPAVIH ANRS CO13 Cohort Study Group; Swiss Hepatitis C Cohort Study Group; French ANRS HC EP 26 Genoscan Study Group. A new 3p25 locus is associated with liver fibrosis progression in human immunodeficiency virus/hepatitis C virus-coinfected patients. Hepatology. 2016 Nov;64(5):1462-1472. doi: 10.1002/hep.28695. Epub 2016 Jul 29.

  PMID: 27339598 RESULT

• Chalouni M, Wittkop L, Bani-Sadr F, Lacombe K, Esterle L, Gilbert C, Miailhes P, Zucman D, Valantin MA, Bregigeon-Ronot S, Morlat P, Billaud E, Piroth L, Naqvi A, Sogni P, Salmon D; ANRS CO13 HEPAVIH Cohort Study Group. Risk of severe clinical events after sustained virological response following direct-acting antiviral therapy in HIV and hepatitis C virus coinfected participants. HIV Med. 2021 Oct;22(9):791-804. doi: 10.1111/hiv.13127. Epub 2021 Jul 1.

  PMID: 34212476 DERIVED

• Chalouni M, Pol S, Sogni P, Fontaine H, Lacombe K, Marc-Lacombe J, Esterle L, Dorival C, Bourliere M, Bani-Sadr F, de Ledinghen V, Zucman D, Larrey D, Salmon D, Carrat F, Wittkop L; ANRS CO13 HEPAVIH and ANRS CO22 HEPATHER cohort study groups. Increased mortality in HIV/HCV-coinfected compared to HCV-monoinfected patients in the DAA era due to non-liver-related death. J Hepatol. 2021 Jan;74(1):37-47. doi: 10.1016/j.jhep.2020.08.008. Epub 2020 Aug 14.

  PMID: 32798585 DERIVED

• Poizot-Martin I, Rosenthal E, Gilbert C, Cano CE, Simon A, Lascoux-Combe C, Alric L, Gervais A, Neau D, Esterle L, Salmon D, Sogni P, Wittkop L; ANRS CO13 HEPAVIH Study Group. Nadir CD4 Is Negatively Associated With Antinuclear Antibody Detection in HCV/HIV-Coinfected Patients. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):461-466. doi: 10.1097/QAI.0000000000001940.

  PMID: 30570526 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Dominique Salmon, MDPhD

  Assistance Publique des Hôpitaux de Paris -Université Paris Descartes

  PRINCIPAL INVESTIGATOR

• Linda Wittkop, MDPhD

  Inserm U1219 CHU de Bordeaux-Université de Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: October 30, 2017
• Study Start: June 1, 2005
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share