Status:
COMPLETED
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
Lead Sponsor:
Judit Pich
Collaborating Sponsors:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
HIV Infections
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03311945
Start Date
May 2 2018
End Date
November 30 2022
Last Update
July 18 2025
Active Locations (1)
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1
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036