A Phase 3 interventional study of Lopinavir and Atazanavir in HIV, sponsored by ANRS, Emerging Infectious Diseases. Withdrawn at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-08.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.
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.
ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
first line treatment failure:
Exclusion Criteria:
Emtricitabine/tenofovir : * TDF300mg.FTC200mg (Fixed Dose Combination) * 1 tablet per day Lopinavir/ritonavir : * LPV200mg/RTV50mg * 2 tablets twice a day
Drug: Lopinavir
Lamivudine/tenofovir : * 3TC300mg/TDF300mg (Fixed Dose Combination) * 1 tablet per day Atazanavir/ritonavir : * ATV300mg/RTV100mg * 2 tablets once a day
Drug: Atazanavir
Evaluation of second line antiretroviral regimen including boosted lopinavir
Evaluation of second line antiretroviral regimen including boosted atazanavir
Virological response
Proportion of patients with plasma HIV RNA \< 50 copies/mL
Time frame: 48 weeks
Virological response
Proportion of patients with plasma HIV RNA \< 400 copies/mL
Time frame: 12 and 24 weeks
Viral resistance
Incidence of resistance mutations after treatment failure (HIV RNA \< 1000 copies/mL)
Time frame: 12, 24 and 48 weeks
Clinical course of HIV infection
Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections
Time frame: Up to 48 weeks
Tolerance assessment
Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks.
Time frame: 24 and 48 weeks
Adherence assessment
Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist
Time frame: At each protocol visit : week 2, 4, 12, 24, 36 and 48
Hepatitis B evaluation
Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline
Time frame: At entry
Immunologic response
Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks
Time frame: 24 and 48 weeks
This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases