Back to resultsStudy to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression (OLE)
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
antiretroviral treatment
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
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
Sites / Locations
- Hospital Clínic i Provincial Barcelona
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
simplification
Continue with current treatment
Arm Description
Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)
Outcomes
Primary Outcome Measures
Proportion of patients with no treatment failure
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
Secondary Outcome Measures
Proportion of patients with no viral failure
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
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
defined as two viral loads above 400 copies/ml
Time to viral failure
Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold
Proportion of patients with blips
Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml
Change from baseline CD4
Lipidic profile change from baseline
Creatinine clearance change from baseline
Proportion of patients with proximal tubular renal disfunction
Lipodystrophy changes from baseline
evaluated using two questionnaires: lipoatrophy and fat accumulation
Adherence to treatment
Mortality and progression to AIDS
Adverse events per treatment branch
Proportion of patients switching study treatment due to an adverse event
Proportion of serious adverse events related to treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01471821
Brief Title
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
Acronym
OLE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simplification
Arm Type
Experimental
Arm Description
Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)
Arm Title
Continue with current treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
antiretroviral treatment
Intervention Description
antiretroviral treatment
Primary Outcome Measure Information:
Title
Proportion of patients with no treatment failure
Description
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
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with no viral failure
Description
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
Time Frame
48 weeks
Title
Proportion of patients with no therapeutical failure
Description
defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome.
Time Frame
48 weeks
Title
Proportion of patients with no viral failure
Description
defined as two viral loads above 400 copies/ml
Time Frame
48 weeks
Title
Time to viral failure
Description
Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold
Time Frame
48 weeks
Title
Proportion of patients with blips
Description
Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml
Time Frame
48 weeks
Title
Change from baseline CD4
Time Frame
48 weeks
Title
Lipidic profile change from baseline
Time Frame
48 weeks
Title
Creatinine clearance change from baseline
Time Frame
48 weeks
Title
Proportion of patients with proximal tubular renal disfunction
Time Frame
48 weeks
Title
Lipodystrophy changes from baseline
Description
evaluated using two questionnaires: lipoatrophy and fat accumulation
Time Frame
48 weeks
Title
Adherence to treatment
Time Frame
48 weeks
Title
Mortality and progression to AIDS
Time Frame
48 weeks
Title
Adverse events per treatment branch
Time Frame
48 weeks
Title
Proportion of patients switching study treatment due to an adverse event
Time Frame
48 weeks
Title
Proportion of serious adverse events related to treatment
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Ramón Arribas, MD
Organizational Affiliation
Hospital Uniuversitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic i Provincial Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26062880
Citation
Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martinez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabie 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.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
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