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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir and truvada; Drug: Atazanavir, Norvir and Truvada

• Registration Number: NCT00762892
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

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 Timeline

• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Study Start: 2009-01
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2014-12
• Results First Submitted: 2014-12-19
• Results First Submitted QC: 2014-12-19
• Last Update Submitted: 2014-12-19
• Results First Posted: 2015-01-05
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltegravir	Raltegravir and truvada	Raltegravir in combination with truvada (tenofovir and emtricitabine)
Atazanavir	Atazanavir, Norvir and Truvada	Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Log HIV Viral Load at 48 Weeks	Baseline and 48 weeks
Change From Baseline in CD4 Count at 48 Weeks	Baseline and 48 weeks

Secondary Outcome Measures

Name	Time	Method
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
Change From Baseline in Lipids at 48 Weeks	Baseline and 48 weeks

Trial Locations

Locations (1)

Thomas Street Clinic; 🇺🇸 Houston, Texas, United States