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

NCT01471821 | Completed Phase 4 DMC

• 1 other identifier: OLE
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks

Secondary Outcomes (15)

• Proportion of patients with no viral failure

  48 weeks

• Proportion of patients with no therapeutical failure

  48 weeks

• Proportion of patients with no viral failure

  48 weeks

• Time to viral failure

  48 weeks

• Proportion of patients with blips

  48 weeks

Study Arms (2)

simplification

EXPERIMENTAL

Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)

Drug: antiretroviral treatment

Continue with current treatment

ACTIVE COMPARATOR

Drug: antiretroviral treatment

Interventions

antiretroviral treatment DRUG

antiretroviral treatment

Continue with current treatment; simplification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex (female or male) and 18 years or older.
• Patients seropositive for HIV-1 using standard diagnostic criteria.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (2)

Hospital Clínic i Provincial Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

• 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. doi: 10.1016/S1473-3099(15)00112-7.

  PMID: 26062880 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• José Ramón Arribas, MD

  Hospital Uniuversitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial Manager

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

ES (2)