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 RA

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

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 to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)

• 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:

• 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 Criteria:

• 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