Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen (RALAM-II)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03333083
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona

Brief Summary:
Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.

Condition or disease Intervention/treatment Phase
HIV Seropositivity HIV Infections HIV-1-infection Drug: Raltegravir Drug: Lamivudine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. RALAM-II Study
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Raltegravir + Lamivudine Drug: Raltegravir
Raltegravir (1200 mg once a day)

Drug: Lamivudine
Lamivudine (300 mg once a day)




Primary Outcome Measures :
  1. Therapeutic failure [ Time Frame: 48 weeks ]
    therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death


Secondary Outcome Measures :
  1. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience [ Time Frame: 48 weeks ]
    Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience

  2. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity [ Time Frame: 48 weeks ]
    Changes on Pittsburgh Sleep Quality Index for neurological toxicity

  3. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity [ Time Frame: 48 weeks ]
    Changes on plasma lipids cholesterol LDL

  4. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity [ Time Frame: 48 weeks ]
    Changes on plasma lipids cholesterol HDL

  5. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity [ Time Frame: 48 weeks ]
    Changes on plasma lipids triglycerides

  6. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity [ Time Frame: 48 weeks ]
    Changes on dual energy x-ray absorptiometry bone density

  7. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity [ Time Frame: 48 weeks ]
    Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort

  8. Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions [ Time Frame: 48 weeks ]
    Proportion of drug-drug interaction with antirretroviral treatment

  9. Therapeutic failure [ Time Frame: 24 weeks ]
  10. Virological failure [ Time Frame: 24 weeks ]
    Defined as two consecutive measurements of plasma viral load above 50 copies/ml

  11. Virological failure [ Time Frame: 48 weeks ]
    Defined as two consecutive measurements of plasma viral load above 50 copies/ml

  12. Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) [ Time Frame: 48 weeks ]
  13. Changes from baseline in cholesterol total [ Time Frame: 24 weeks ]
  14. Changes from baseline in HDL [ Time Frame: 24 weeks ]
  15. Changes from baseline in triglycerides [ Time Frame: 24 weeks ]
  16. Changes from baseline in insulin resistance (HOMA-IR) [ Time Frame: 24 weeks ]
  17. Changes from baseline in cholesterol LDL [ Time Frame: 24 weeks ]
  18. Changes from baseline in cholesterol LDL [ Time Frame: 48 weeks ]
  19. Changes from baseline in cholesterol total [ Time Frame: 48 weeks ]
  20. Changes from baseline in cholesterol HDL [ Time Frame: 48 weeks ]
  21. Changes from baseline in triglycerides [ Time Frame: 48 weeks ]
  22. Changes from baseline in and insulin resistance (HOMA-IR) [ Time Frame: 48 weeks ]
  23. Changes from baseline in body fat composition [ Time Frame: 48 weeks ]
  24. Changes from baseline in immune activation markers including CD38 [ Time Frame: 48 weeks ]
  25. Changes from baseline in immune activation markers including HLA-DR [ Time Frame: 48 weeks ]
  26. Changes from baseline in biomarkers of inflammation IL-6, [ Time Frame: 48 weeks ]
  27. Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein [ Time Frame: 48 weeks ]
  28. Changes from baseline in biomarkers of mononuclear activation SD-14 [ Time Frame: 48 weeks ]
  29. Changes from baseline in biomarkers of mononuclear activation SD-163 [ Time Frame: 48 weeks ]
  30. Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) [ Time Frame: 24 weeks ]
  31. Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) [ Time Frame: 48 weeks ]
  32. Change from baseline in EQ-5D-5L [ Time Frame: 24 weeks ]
  33. Change from baseline in EQ-5D-5L [ Time Frame: 48 weeks ]
  34. Incidence of adverse events [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
  • Patients seropositive for HIV-1 using standard diagnostic criteria.
  • Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
  • Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
  • Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Previous failure to an integrase inhibitor-containing regimen.
  • Previous failure to a Lamivudine or Emtricitabine-containing regimen.
  • Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
  • 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.
  • Chronic hepatitis B.

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 ClinicalTrials.gov identifier (NCT number): NCT03333083


Contacts
Layout table for location contacts
Contact: Esteban Martinez, MD +34.93.227.54.00 ESTEBANM@clinic.cat

Locations
Layout table for location information
Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Esteban Martinez, MD    +34.93.227.54.00    ESTEBANM@clinic.cat   
Principal Investigator: Esteban Martínez, MD         
Sponsors and Collaborators
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica

Layout table for additonal information
Responsible Party: David Garcia Cinca, Clinical Research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03333083     History of Changes
Other Study ID Numbers: 2017-000985-31
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Garcia Cinca, Hospital Clinic of Barcelona:
Lamivudine
Raltegravir

Additional relevant MeSH terms:
Layout table for MeSH terms
Lamivudine
Infection
Communicable Diseases
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors