Text Size

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

This study is currently recruiting participants.
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01471821
First received: November 15, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
HIV Infection
 Drug: antiretroviral treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Proportion of patients with no treatment failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    defined as two viral loads above 400 copies/ml

  • Time to viral failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Lipidic profile change from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Creatinine clearance change from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with proximal tubular renal disfunction [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Lipodystrophy changes from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    evaluated using two questionnaires: lipoatrophy and fat accumulation

  • Adherence to treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Mortality and progression to AIDS [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Adverse events per treatment branch [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients switching study treatment due to an adverse event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of serious adverse events related to treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 336
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471821

Contacts
Contact: Josep Maria Gatell, MD 0034932275430 jmgatell@clinic.ub.es

Locations
Spain
Hospital Clínic i Provincial Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Josep Mallolas, MD            
Principal Investigator: Josep Mallolas, MD            
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: José Ramón Arribas, MD            
Principal Investigator: José Ramón Arribas, MD            
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Principal Investigator: José Ramón Arribas, MD Hospital Uniuversitario La Paz
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, Clinical Trial Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01471821     History of Changes
Other Study ID Numbers: OLE
Study First Received: November 15, 2011
Last Updated: February 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Ritonavir
 Lopinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013