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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir and truvada
* Drug: Atazanavir, Norvir and Truvada


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve