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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471821
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: antiretroviral treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: simplification
Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)
Drug: antiretroviral treatment
antiretroviral treatment

Active Comparator: Continue with current treatment Drug: antiretroviral treatment
antiretroviral treatment

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Proportion of patients with no viral failure [ Time Frame: 48 weeks ]
    defined as two viral loads above 400 copies/ml

  4. 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

  5. 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

  6. Change from baseline CD4 [ Time Frame: 48 weeks ]
  7. Lipidic profile change from baseline [ Time Frame: 48 weeks ]
  8. Creatinine clearance change from baseline [ Time Frame: 48 weeks ]
  9. Proportion of patients with proximal tubular renal disfunction [ Time Frame: 48 weeks ]
  10. Lipodystrophy changes from baseline [ Time Frame: 48 weeks ]
    evaluated using two questionnaires: lipoatrophy and fat accumulation

  11. Adherence to treatment [ Time Frame: 48 weeks ]
  12. Mortality and progression to AIDS [ Time Frame: 48 weeks ]
  13. Adverse events per treatment branch [ Time Frame: 48 weeks ]
  14. Proportion of patients switching study treatment due to an adverse event [ Time Frame: 48 weeks ]
  15. Proportion of serious adverse events related to treatment [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471821

Hospital Clínic i Provincial Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Juan A. Arnaiz
Principal Investigator: José Ramón Arribas, MD Hospital Uniuversitario La Paz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Juan A. Arnaiz, Clinical Trial Manager, Hospital Clinic of Barcelona Identifier: NCT01471821     History of Changes
Other Study ID Numbers: OLE
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors