Status:
COMPLETED
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
Lead Sponsor:
Juan A. Arnaiz
Conditions:
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combin...
Eligibility Criteria
Inclusion
- 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 virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
- Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
- Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
- Patients who have signed informed consent to participate in the study.
Exclusion
- Pregnancy, lactation, or planned pregnancy during the study period.
- Previous failure to an integrase inhibitor-containing regimen.
- Previous failure to a 3TC or FTC-containing regimen.
- Resistance mutations to 3TC 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.
Key Trial Info
Start Date :
September 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02284035
Start Date
September 27 2015
End Date
February 28 2017
Last Update
July 20 2025
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036