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Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression (OLE)

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ClinicalTrials.gov Identifier: NCT01471821
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):

November 15, 2011
November 16, 2011
July 29, 2014
October 2011
April 2014   (Final data collection date for primary outcome measure)
Proportion of patients with no treatment failure [ Time Frame: 48 weeks ]
  • viral failure, defined as two viral loads above 50 copies/ml at least two weeks apart
  • death
  • developing new CDC-C events
  • withdrawing consent
  • being lost to follow-up
  • switching assigned treatment for any cause
Same as current
Complete list of historical versions of study NCT01471821 on ClinicalTrials.gov Archive Site
  • Proportion of patients with no viral failure [ Time Frame: 48 weeks ]
    defined as two viral loads above 50 copies/ml. Patients lost to follow-up or changing treatment will not be taken into account for this analysis
  • Proportion of patients with no therapeutical failure [ Time Frame: 48 weeks ]
    defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome.
  • Proportion of patients with no viral failure [ Time Frame: 48 weeks ]
    defined as two viral loads above 400 copies/ml
  • Time to viral failure [ Time Frame: 48 weeks ]
    Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold
  • Proportion of patients with blips [ Time Frame: 48 weeks ]
    Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml
  • Change from baseline CD4 [ Time Frame: 48 weeks ]
  • Lipidic profile change from baseline [ Time Frame: 48 weeks ]
  • Creatinine clearance change from baseline [ Time Frame: 48 weeks ]
  • Proportion of patients with proximal tubular renal disfunction [ Time Frame: 48 weeks ]
  • Lipodystrophy changes from baseline [ Time Frame: 48 weeks ]
    evaluated using two questionnaires: lipoatrophy and fat accumulation
  • Adherence to treatment [ Time Frame: 48 weeks ]
  • Mortality and progression to AIDS [ Time Frame: 48 weeks ]
  • Adverse events per treatment branch [ Time Frame: 48 weeks ]
  • Proportion of patients switching study treatment due to an adverse event [ Time Frame: 48 weeks ]
  • Proportion of serious adverse events related to treatment [ Time Frame: 48 weeks ]
Same as current
Not Provided
Not Provided
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy Instead of a Triple Therapy That Includes Lopinavir/Ritonavir and Lamivudine or Emtricitabine in HIV Patients With Viral Suppression: Controlled Clinical Trial, Open Label, Randomized, of 48 Weeks of Follow-up

This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine.

Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
Drug: antiretroviral treatment
antiretroviral treatment
  • Experimental: simplification
    Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)
    Intervention: Drug: antiretroviral treatment
  • Active Comparator: Continue with current treatment
    Intervention: Drug: antiretroviral treatment
Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martínez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabié A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7. Erratum in: Lancet Infect Dis. 2015 Aug;15(8):875.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of either sex (female or male) and 18 years or older.
  • Patients seropositive for HIV-1 using standard diagnostic criteria.
  • There is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. The requirement is to have at least two viral loads lower than 50 cop/mL separated by 6 months and no one >50cop/mL during the 6 months before inclusion.
  • Patients on continuous HAART consisting of LPV/r, emtricitabine (FTC) or 3TC (lamivudine) and an NRTI for at least 2 months before being randomized in this study.
  • Patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). Patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. Standard prophylaxis of opportunistic infections is permitted.

Exclusion Criteria:

  • Pregnancy, nursing, or planned pregnancy during the study period.
  • Previous failure with regimens including a protease inhibitor (PI) or 3TC/FTC.
  • Known resistance mutations to PIs or 3TC/FTC.
  • Patients with an active opportunistic infection or malignancy. Patients with a stable chronic opportunistic infection may be included in the study.
  • Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
  • Patients diagnosed with visceral Kaposi's sarcoma (KS), patients with lymphoedema secondary to cutaneous KS or cutaneous or palatine KS who have been treated with systemic immunosuppressive therapy must also be excluded.
  • Patients with chronic hepatitis B on treatment with tenofovir + 3TC/FTC
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Principal Investigator: José Ramón Arribas, MD Hospital Uniuversitario La Paz
Hospital Clinic of Barcelona
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP