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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Raltegravir and truvada; Drug: Atazanavir, Norvir and Truvada

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77009
      • Thomas Street Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Raltegravir; Raltegravir in combination with truvada (tenofovir and emtricitabine)	Drug: Raltegravir and truvada; Raltegravir 400 mg po bid, truvada 1 tab q daily; Other Names: Truvada is tenofovir 300 mg and emtricitabine 200 mg
Active Comparator: Atazanavir; Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)	Drug: Atazanavir, Norvir and Truvada; Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily; Other Names: Truvada is tenofovir 300 mg and emtricitabine 200 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Tanvir K Bell, MD, UT-Houston

Publications and helpful links

Helpful Links

• open access journal

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Lipids; Raltegravir; Protease inhibitor; Treatment Naïve; HIV disease; Naive patients; Integrase inhibitor
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Atazanavir Sulfate
• Other Study ID Numbers: raltegravir atazanavir naive