Clinical trial NCT02284035: Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
Official title: Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: AIDS
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients seropositive for HIV-1 using standard diagnostic criteria.
3. Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
4. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
5. 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).
6. Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

1. Pregnancy, lactation, or planned pregnancy during the study period.
2. Previous failure to an integrase inhibitor-containing regimen.
3. Previous failure to a 3TC or FTC-containing regimen.
4. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
5. 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.
6. Chronic hepatitis B.

Primary outcomes:
measure: Efficacy in virological suppression assessed with standard plasma HIV-1 RNA detection
timeFrame: 24 weeks
Secondary outcomes:
measure: Efficacy in virological suppression assessed with ultrasensitive HIV-1 RNA detection (limit of detection 1 copy/mL)
timeFrame: 24 weeks
measure: changes in peripheral mononuclear blood cells HIV-1 reservoir
timeFrame: 24 weeks
measure: changes in insulin resistance (HOMA-IR)
timeFrame: 24 weeks
measure: changes in body fat composition
timeFrame: 24 weeks
measure: changes in plasma 25-OH vitamin D levels
timeFrame: 24 weeks
measure: changes in estimated glomerular filtration rate (CKD-EPI)
timeFrame: 24 weeks
measure: changes in CD38
timeFrame: 24 weeks
measure: changes in IL-6
timeFrame: 24 weeks
measure: changes in sleep quality (Pittsburgh Sleep Quality Index)
timeFrame: 24 weeks
measure: changes in adherence in both treatment arms (Morisky-Green Test)overall tolerability
timeFrame: 24 weeks
measure: Changes in total cholesterol
timeFrame: 24 weeks
measure: Changes in HDL cholesterol
timeFrame: 24 weeks
measure: Changes in LDL cholesterol
timeFrame: 24 weeks
measure: Changes in triglycerides
timeFrame: 24 weeks
measure: Changes in bone mineral density
timeFrame: 24 weeks
measure: Changes in urine beta-2-microglobulin
timeFrame: 24 weeks
measure: changes in HLA-DR
timeFrame: 24 weeks
measure: Changes in high sensitivity C-reactive protein
timeFrame: 24 weeks
measure: Changes in mononuclear activation SD-14
timeFrame: 24 weeks
measure: Changes in mononuclear activation SD-163
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Esteban Martinez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: