A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir
NCT ID: NCT01255371
Last Updated: 2012-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-03-31
2014-12-31
Brief Summary
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This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus \> 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A : Lopinavir
Emtricitabine/tenofovir :
* TDF300mg.FTC200mg (Fixed Dose Combination)
* 1 tablet per day
Lopinavir/ritonavir :
* LPV200mg/RTV50mg
* 2 tablets twice a day
Lopinavir
Evaluation of second line antiretroviral regimen including boosted lopinavir
Arm B : Atazanavir
Lamivudine/tenofovir :
* 3TC300mg/TDF300mg (Fixed Dose Combination)
* 1 tablet per day
Atazanavir/ritonavir :
* ATV300mg/RTV100mg
* 2 tablets once a day
Atazanavir
Evaluation of second line antiretroviral regimen including boosted atazanavir
Interventions
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Lopinavir
Evaluation of second line antiretroviral regimen including boosted lopinavir
Atazanavir
Evaluation of second line antiretroviral regimen including boosted atazanavir
Eligibility Criteria
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Inclusion Criteria
* out patient
* documented HIV-1 infection
* first line treatment failure:
* after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors
* two measurements of plasma HIV RNA levels \> 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification
* satisfactory compliance (\>80%) to 1st line antiretroviral treatment
* signed informed consent
* agreement for contraception for women of childbearing age
Exclusion Criteria
* uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB
* first line antiretroviral treatment with a protease inhibitor or tenofovir
* ongoing treatment with rifampicin
* severe hepatic insufficiency (PT \< 50%)
* ALT \< 3 times the upper limit of normal
* creatinine clearance calculated by Cockcroft's formula \< 50 mL/min
* Hb \<=8 g/dL; platelets \< 50,000 cells/mm3; neutrophils \< 500 cells/mm3
* pregnancy and lactation
18 Years
ALL
No
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Ludwig-Maximilians - University of Munich
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Institut de Recherche pour le Developpement
OTHER_GOV
Swiss National Science Foundation
OTHER
University of Limpopo
OTHER
NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania
UNKNOWN
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Eric Delaporte
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche pour le Developpement
Issakwisa Mwakyula
Role: PRINCIPAL_INVESTIGATOR
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania
Mzileni O Mogiyana
Role: PRINCIPAL_INVESTIGATOR
University of Limpopo
Alexandra Calmy
Role: PRINCIPAL_INVESTIGATOR
University of Geneva, Switzerland
Locations
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Tshepang clinic, Limpopo University
Pretoria, , South Africa
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital
Mbeya, , Tanzania
Countries
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Other Identifiers
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IP.07.33011.004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANRS 12221 ALISA
Identifier Type: -
Identifier Source: org_study_id