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Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM (RALAM-RollOver)

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ClinicalTrials.gov Identifier: NCT03311945
Recruitment Status : Recruiting
First Posted : October 17, 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, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)
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

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Raltegravir + Lamivudine
Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
Drug: Raltegravir
Raltegravir (1200 mg QD)

Drug: Lamivudine
Lamivudine (300 mg QD)




Primary Outcome Measures :
  1. Proportion of patients with herapeutic failure [ Time Frame: 48 weeks ]
    Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death


Secondary Outcome Measures :
  1. Proportion of patients with herapeutic failure [ Time Frame: 24 weeks ]
    Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death

  2. Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) [ Time Frame: 48 weeks ]
  3. Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir [ Time Frame: 48 weeks ]
  4. Changes from baseline in cholesterol total [ Time Frame: 24 weeks ]
  5. Changes from baseline in cholesterol LDL [ Time Frame: 24 weeks ]
  6. Changes from baseline in cholesterol HDL [ Time Frame: 24 weeks ]
  7. Changes from baseline in triglycerides [ Time Frame: 24 weeks ]
  8. Changes from baseline in insulin resistance (HOMA-IR) [ Time Frame: 24 weeks ]
  9. Changes from baseline in cholesterol total [ Time Frame: 48 weeks ]
  10. Changes from baseline in cholesterol LDL [ Time Frame: 48 weeks ]
  11. Changes from baseline in triglycerides [ Time Frame: 48 weeks ]
  12. Changes from baseline in insulin resistance (HOMA-IR) [ Time Frame: 48 weeks ]
  13. Change from baseline in lumbar and femoral bone mineral density [ Time Frame: 48 weeks ]
  14. Change from baseline in plasma 25-OH vitamin D levels [ Time Frame: 48 weeks ]
  15. Change from baseline in urine beta-2-microglobulin [ Time Frame: 48 weeks ]
  16. Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI) [ Time Frame: 48 weeks ]
  17. Change from baseline in urine protein/creatinine ratio [ Time Frame: 48 weeks ]
  18. Changes from baseline in biomarkers of inflammation IL-6 [ Time Frame: 48 weeks ]
  19. Changes from baseline in biomarker of mononuclear activation SD-163 [ Time Frame: 48 weeks ]
  20. Changes from baseline in biomarker of mononuclear activation SD-14 [ Time Frame: 48 weeks ]
  21. Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein [ Time Frame: 48 weeks ]
  22. Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at [ Time Frame: 48 weeks ]
  23. Change from baseline in EQ-5D-5L [ Time Frame: 48 weeks ]
  24. Incidence of adverse events [ 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
Criteria

Inclusion Criteria:

  • Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load <50 copies/mL) on dual therapy with lamivudine plus Raltegravir
  • Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

  • Pregnancy, lactation, or planned pregnancy during the study period
  • Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
  • Hepatitis B co-infection

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): NCT03311945


Contacts
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Contact: Esteban Martinez, MD +34.227.54.00 ESTEBANM@clinic.cat

Locations
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Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Esteban Martinez, MD    +34.227.54.00    ESTEBANM@clinic.cat   
Principal Investigator: Esteban Martínez, MD         
Sponsors and Collaborators
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica

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Responsible Party: David Garcia Cinca, Clinical Research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03311945     History of Changes
Other Study ID Numbers: 2017-000986-60
First Posted: October 17, 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

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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:
Raltegravir
Lamivudine

Additional relevant MeSH terms:
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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