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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

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.