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

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.

Full Title of Study: “A Pilot Study–randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 2012

Detailed Description

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.

Interventions

• Drug: Raltegravir and truvada
  • Raltegravir 400 mg po bid, truvada 1 tab q daily
• Drug: Atazanavir, Norvir and Truvada
  • Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Arms, Groups and Cohorts

• Active Comparator: Raltegravir
  • Raltegravir in combination with truvada (tenofovir and emtricitabine)
• Active Comparator: Atazanavir
  • Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Clinical Trial Outcome Measures

Primary Measures

• Change From Baseline in CD4 Count at 48 Weeks
  • Time Frame: Baseline and 48 weeks
• Change From Baseline in Log HIV Viral Load at 48 Weeks
  • Time Frame: Baseline and 48 weeks

Secondary Measures

• Change From Baseline in Lipids at 48 Weeks
  • Time Frame: Baseline and 48 weeks
• Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
  • Time Frame: Baseline and 48 weeks
• Change From Baseline in Homocysteine at 6 Months
  • Time Frame: Baseline and 48 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The University of Texas Health Science Center, Houston
• Collaborator
  • Merck Sharp & Dohme LLC
• Provider of Information About this Clinical Study
  • Principal Investigator: Tanvir K. Bell, MD, Associate Professor – The University of Texas Health Science Center, Houston
• Overall Official(s)
  • Tanvir K Bell, MD, Principal Investigator, UT-Houston