Overview

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.