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

• Status: Unknown status
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Garcia Cinca
• Collaborators: Fundació Clínic per a la Recerca Biomèdica; Fundacion Clinic per a la Recerca Biomédica
• Treatments: Lamivudine; Raltegravir Potassium

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.