Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

Juan A. Arnaiz75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AIDS

Interventions

Raltegravir/3TCDRUG

MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.

EFV/TDF/FTCDRUG

standard combination therapy

ATV/r + TDF/FTC or DRV/r + TDF/FTCDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic

Barcelona, Spain

Outcomes

Primary Outcomes

Proportion of Patients Free of Therapeutic Failure

Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

Time frame: 24 weeks

Secondary Outcomes

Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)

Time frame: 24 weeks

Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir

Time frame: 24 weeks

Changes in Insulin Resistance (HOMA-IR)

Composite measure

Time frame: 24 weeks

Changes in Body Fat Composition

Composite measure

Time frame: 24 weeks

Changes in Plasma 25-OH Vitamin D Levels

Time frame: 24 weeks

Changes in Estimated Glomerular Filtration Rate (CKD-EPI)

Composite measure

Time frame: 24 weeks

Changes in CD38

Time frame: 24 weeks

Changes in IL-6

Time frame: 24 weeks

Changes in Sleep Quality (Pittsburgh Sleep Quality Index)

The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.