Status:
TERMINATED
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
Lead Sponsor:
Judit Pich
Collaborating Sponsors:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
HIV Seropositivity
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 inconvenien...
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 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
- 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.
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03333083
Start Date
May 3 2018
End Date
June 25 2020
Last Update
May 18 2025
Active Locations (1)
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1
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, Spain, 08036