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

NCT03333083 | Terminated Phase 3 DMC

• 2 other identifiers: RALAM-II2017-000985-31
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity; HIV Infections; HIV-1-infection

Keywords

Lamivudine; Raltegravir

Outcome Measures

Primary Outcomes (1)

• Therapeutic failure

  therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

  48 weeks

Secondary Outcomes (34)

• Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience

  48 weeks

• Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity

  48 weeks

• 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

  48 weeks

• 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

  48 weeks

• 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

  48 weeks

Study Arms (1)

Raltegravir + Lamivudine

EXPERIMENTAL

Drug: Raltegravir; Drug: Lamivudine

Interventions

Raltegravir DRUG

Raltegravir (1200 mg once a day)

Raltegravir + Lamivudine

Lamivudine DRUG

Lamivudine (300 mg once a day)

Raltegravir + Lamivudine

Eligibility Criteria

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

You may qualify if:

• 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 who have signed informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Judit Pich: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV Seropositivity; HIV Infections

Interventions

Raltegravir Potassium; Lamivudine

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 6, 2017
• Study Start: May 3, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)