Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients

The University of Texas Health Science Center, Houston33 enrolled

Overview

This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.

We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Raltegravir and truvadaDRUG

Raltegravir 400 mg po bid, truvada 1 tab q daily

Atazanavir, Norvir and TruvadaDRUG

Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must be HIV-1 positive and naïve to HIV therapy. * Patients must plan to participate and be available for the trial for the 96-week study period. * Patients followed at Thomas Street Clinic. * Patients must be over 18 years old. Exclusion Criteria: * Patients must not be pregnant or plan to become pregnant over the 96-week study period. * Patients cannot be on a proton pump inhibitor. * Patients cannot be undergoing treatment for active tuberculosis. * Renal Insufficiency with a creatinine clearance \< 50 ml/min/1.73 m2 by the MDRD GFR calculation.

Locations (1)

Thomas Street Clinic

Houston, Texas, United States