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 combination therapy in HIV-infected patients with prolonged virological suppression. RALAM Study

Phase 1

Conditions: Chronic HIV infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-003142-27-ES

Lead Sponsor: Fundació Clinic per a la Recerca Biomédica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a. 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.
b. Patients seropositive for HIV-1 using standard diagnostic criteria.
c. Patients virologicaly suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
d. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
e. 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).
f. Patients who have signed informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

a. Pregnancy, lactation, or planned pregnancy during the study period.
b. Previous failure to an integrase inhibitor-containing regimen.
c. Previous failure to a 3TC or FTC-containing regimen.
d. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
e. 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.
f. Chronic hepatitis B.
g. Current therapy with RAL+3TC