Clinical trial NCT01471821: Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients with no treatment failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients with no viral failure
timeFrame: 48 weeks
measure: Proportion of patients with no therapeutical failure
timeFrame: 48 weeks
measure: Proportion of patients with no viral failure
timeFrame: 48 weeks
measure: Time to viral failure
timeFrame: 48 weeks
measure: Proportion of patients with blips
timeFrame: 48 weeks
measure: Change from baseline CD4
timeFrame: 48 weeks
measure: Lipidic profile change from baseline
timeFrame: 48 weeks
measure: Creatinine clearance change from baseline
timeFrame: 48 weeks
measure: Proportion of patients with proximal tubular renal disfunction
timeFrame: 48 weeks
measure: Lipodystrophy changes from baseline
timeFrame: 48 weeks
measure: Adherence to treatment
timeFrame: 48 weeks
measure: Mortality and progression to AIDS
timeFrame: 48 weeks
measure: Adverse events per treatment branch
timeFrame: 48 weeks
measure: Proportion of patients switching study treatment due to an adverse event
timeFrame: 48 weeks
measure: Proportion of serious adverse events related to treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Uniuversitario La Paz
name: José Ramón Arribas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.