A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
NCT ID: NCT00931463
Last Updated: 2019-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
558 participants
INTERVENTIONAL
2009-09-30
2013-08-31
Brief Summary
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The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
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Detailed Description
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Eligible patients will be randomised to one of two arms:
I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs
II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA \< 200 copies/mL 48 weeks after randomisation.
Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints.
Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ritonavir-boosted lopinavir and 2N(t)RTI
This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
2N(t)RTI
2N(t)RTIs as prescribed
Ritonavir-boosted lopinavir
2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours
Ritonavir-boosted lopinavir and raltegravir
This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
raltegravir
400 mg raltegravir tablet taken every 12 hours
Ritonavir-boosted lopinavir
2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours
Interventions
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raltegravir
400 mg raltegravir tablet taken every 12 hours
2N(t)RTI
2N(t)RTIs as prescribed
Ritonavir-boosted lopinavir
2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for at least 24 weeks
4. No change in antiretroviral therapy within 12 weeks prior to screening
5. Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (at least 7 days apart) HIV RNA results of greater then 500 copies/mL
6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
7. Able to provide written informed consent
Exclusion Criteria
* absolute neutrophil count (ANC) \< 500 cells/microlitres
* hemoglobin \< 7.0 g/decilitres
* platelet count \< 50,000 cells/microlitres
* ALT great than 5 x ULN
2. Pregnant or nursing mothers
3. Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
4. Use of immunomodulators within 30 days prior to screening
5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
6. Intercurrent illness requiring hospitalization
7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
8. Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
9. Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
16 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Abbott
INDUSTRY
amfAR, The Foundation for AIDS Research
OTHER
Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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David A Cooper, MD
Role: STUDY_CHAIR
Kirby Institute
Brian Gazzard, MD
Role: STUDY_CHAIR
St. Stephen's Trust
Locations
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Hospital Interzonal General de Agudos, Oscar Alende
Buenos Aires, Mar Del Plata Provincia, Argentina
CAICI
Buenos Aires, Rosario Provincia de Sante Fe, Argentina
Hospital General de Agudos 'Teodoro Alvarez'
Buenos Aires, , Argentina
FUNCEI
Buenos Aires, , Argentina
Hospital de Infecciosas FJ Muniz
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
Hospital J.M. Ramos Mejia
Buenos Aires, , Argentina
Hospital Prof. Alejandro Posadas
Buenos Aires, , Argentina
Hospital Rawson
Córdoba, , Argentina
Hospital Central
Mendoza, , Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
Albion Street Centre
Sydney, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Centre Clinic
Melbourne, Victoria, Australia
Hospital de la Universidad Catolica Pontificia
Santiago, , Chile
Hospital San Borja-Arriaran
Santiago, , Chile
Hopital Saint-Louis
Paris, , France
Medical Group Practice
Berlin, , Germany
J W Goethe Universitat
Frankfurt, , Germany
Queen Elizabeth Hospital
Hong Kong, Kowloon, Hong Kong
YRG Care
Chennai, , India
Institute of Infectious Diseases
Pune, , India
Mater Misericordiae-Dublin
Dublin, , Ireland
Hospital Pelau Pinang
Kuala Lumpur, , Malaysia
Hospital Sungai Buloh
Kuala Lumpur, , Malaysia
University of Malaysia
Kuala Lumpur, , Malaysia
Hospital General de Guadalajara
Guadalajara, , Mexico
Hospital General de Leon
León, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran"
Mexico City, , Mexico
Auckland Hospital
Grafton, Auckland, New Zealand
Evangel Hospital (ECWA)
Jos, Plateau State, Nigeria
Jos University Teaching Hospital (JUTH)
Jos, Plateau State, Nigeria
Plateau State Specialist Hospital
Jos, Plateau State, Nigeria
Hospital Almenara
Lima, , Peru
IMPACTA/Hospital Dos de Mayo
Lima, , Peru
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia
Lima, , Peru
Via Libre
Lima, , Peru
Tan Tock Seng Hospital
Singapore, , Singapore
Josha Research
Bloemfontein, , South Africa
Desmond Tutu HIV Foundation
Cape Town, , South Africa
Chris Hani Baragwanath Hospital
Soweto, , South Africa
National Taiwan University Hospital
Taipei, , Taiwan
Chelsea and Westminster Hospital
Fulham, London, United Kingdom
Countries
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References
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Henry RT, Jiamsakul A, Law M, Losso M, Kamarulzaman A, Phanuphak P, Kumarasamy N, Foulkes S, Mohapi L, Nwizu C, Wood R, Kelleher A, Polizzotto M; SECOND-LINE Study Group. Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants. J Acquir Immune Defic Syndr. 2021 May 1;87(1):720-729. doi: 10.1097/QAI.0000000000002619.
Amin J, Boyd MA, Kumarasamy N, Moore CL, Losso MH, Nwizu CA, Mohapi L, Kerr SJ, Sohn AH, Teppler H, Renjifo B, Molina JM, Emery S, Cooper DA. Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection. PLoS One. 2015 Feb 27;10(2):e0118228. doi: 10.1371/journal.pone.0118228. eCollection 2015.
Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013.
SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.
Other Identifiers
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SECOND-LINE
Identifier Type: -
Identifier Source: org_study_id
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